MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM 0 OFFSET; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Catalog Number	6260-9-136
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Fall (1848); Metal Related Pathology (4530)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of a capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before march 4, 2011.The root cause analysis identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
It was reported that the patient's left hip was revised.The patient had fallen 8 months prior to revision and sustained an acetabular fracture.Non-operative treatment failed, and the shell loosened.Once the patient was open, surgeon noted black tissue inside the patient.After removing the head from the stem, black material was seen inside the head and moderate trunnion wear was noted.The patient's hip construct was revised to a competitor hip.Rep confirmed there were no allegations against the revised liner.Rep confirmed there was no head dissociation.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
An event regarding wear involving a metal head was reported.The event was confirmed through visual inspection.Method & results -product evaluation and results: visual inspection of the provided photograph indicated that the head has evidence of wear due to the presence of black debris internally.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: 'the operative note documents a revision surgery was performed.Unfortunately, in the documentation provided no intra-operative findings were noted.Revision tha surgery is confirmed.The cause for this revision tha cannot be determined from the limited documentation provided.' -product 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 lot referenced.Conclusions: it was reported that the patient's left hip was revised.The patient had fallen 8 months prior to revision and sustained an acetabular fracture.Non-operative treatment failed, and the shell loosened.Once the patient was open, surgeon noted black tissue inside the patient.After removing the head from the stem, black material was seen inside the head and moderate trunnion wear was noted.The patient's hip construct was revised to a competitor hip.Rep confirmed there were no allegations against the revised liner.A review of the provided medical records by a clinical consultant indicated: 'the operative note documents a revision surgery was performed.Unfortunately, in the documentation provided no intra-operative findings were noted.Revision tha surgery is confirmed.The cause for this revision tha cannot be determined from the limited documentation provided.' the subject device has been identified to be within scope of lot specific voluntary recall that was initiated for the lfit v40 cocr heads within scope of a capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before march 4, 2011.The root cause analysis identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.

• Brand Name: V40 COCR LFIT HEAD 36MM 0 OFFSET
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22165319
• Report Number: 0002249697-2025-00610
• Device Sequence Number: 9401756
• Product Code: JDI
• UDI-Device Identifier: 07613327032307
• UDI-Public: 07613327032307
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

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: 11/30/2012
• Device Catalogue Number: 6260-9-136
• Device Lot Number: E7MMPD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2007
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2249697-05-07-2018-003-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female