MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +4 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-9-232
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	01/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There has been 1 similar event for the lot referenced.
Event or Problem Description
It was reported that the patient required revision hip surgery due to a dissociation between the head and femoral stem and the substantial damage to the femoral trunion.It was further reported that the revision was performed after the patient presented to emergency department with a dislocation that appeared unusual on xray >10 years post hip replacement.
Event or Problem Description
It was reported that the patient required revision hip surgery due to a dissociation between the head and femoral stem and the substantial damage to the femoral trunion.It was further reported that the revision was performed after the patient presented to emergency department with a dislocation that appeared unusual on xray >10 years post hip replacement.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a metal head was reported.The event was confirmed through clinician review of the provided medical records.Method & results: -device evaluation and results: the device was returned for evaluation.Scratches are visible on the rim of the head.Material evaluation was completed and indicated the following comments: damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.No further material analyses were performed.-clinician review: a review of the provided medical records by a clinical consultant indicated: this inquiry reports the failure of a right total hip replacement about 10 years after implantation (according to the information in the event description) due to trunnion failure and disassociation.I can confirm that this event took place since i was able to view an xray and photos of the explanted device.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of trunnion failure and disassociation are multifactorial including surgical technique factors, patient activity, weight, and implant factors.The large notch on the inferior aspect of the stem suggests impingement.-device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: the device was returned for evaluation.Scratches are visible on the rim of the head.Material evaluation was completed and indicated the following comments: damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.A review of the provided medical records by a clinical consultant indicated: this inquiry reports the failure of a right total hip replacement about 10 years after implantation (according to the information in the event description) due to trunnion failure and disassociation.I can confirm that this event took place since i was able to view an xray and photos of the explanted device.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of trunnion failure and disassociation are multifactorial including surgical technique factors, patient activity, weight, and implant factors.The large notch on the inferior aspect of the stem suggests impingement.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: 32MM +4 LFIT V40 HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13392224
• Report Number: 0002249697-2022-00148
• Device Sequence Number: 17117400
• Product Code: JDI
• UDI-Device Identifier: 07613327013085
• UDI-Public: 07613327013085
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K010757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: 6260-9-232
• Device Catalogue Number: 6260-9-232
• Device Lot Number: 35171703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown