Evaluation summary: no product was returned for evaluation and the condition of the devices are unknown.
It is unlikely that the kinectiv modular neck and m/l taper with kinectiv components contributed to the alleged event of acetabular component loosening and pain.
The surgical notes from the primary surgery are unavailable, and it is unknown if the stem and neck were implanted with the correct orientation and correct fit as per surgical technique.
X-ray images post-primary surgery and from successive patient visits are unavailable.
The instruments used in the primary surgery are also unknown.
Patient height, weight, and activity level are unknown.
Factors which may contribute to acetabular loosening pertaining to the kinectiv modular neck and m/l taper with kinectiv components may be one or a combination of the following mechanism: improper neck length and offset, misalignment of femoral stem/neck assembly, extent of mating connectivity between stem/neck/head interfaces, impingement, or patient activity post-surgery.
However, the exact cause for the current situation cannot be conclusively determined.
Evaluation: no product was returned.
Review of the device history records did not find any deviations or anomalies.
It is not suspected that the product failed to meet specifications.
The investigation could not verify or identify any evidence of product contribution to the reported problem.
Based on the investigation, the need for corrective action is not indicated.
Should additional substantive information be received, the complaint will be reopened.
Considers the investigation closed.
It is reported by the patient that the device was implanted in 2008, and that post op, the patient has experienced pain in the groin area.
Revision surgery has been recommended, but has not yet taken place.