MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/-4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-040
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported 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.
Event or Problem Description
It was reported that there is an upcoming accolade revision surgery.Patient needed a revision surgery to replace the stem and head.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a metal head was reported.The event was confirmed through visual inspection of the photos provided.Method & results: -product evaluation and results: visual inspection of the provided photograph indicated loss of taper lock between the head and stem of the returned devices.-clinician review: no medical records were provided for review with a clinical consultant.-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: visual inspection of the provided photograph indicated loss of taper lock between the head and stem of the returned devices.The subject device has been identified to be within scope of nc and capa.Lot specific voluntary recall pfa 1757583 was initiated for the lfit v40 cocr heads within scope of nc and 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 analyses identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a metal head was reported.The event was confirmed through visual inspection of the photos provided.Method & results: product evaluation and results: visual inspection of the provided photograph indicated loss of taper lock between the head and stem.Clinician review: no medical records were provided for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock on 10/10/2007 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: visual inspection of the provided photograph indicated loss of taper lock between the head and stem.The subject device has been identified to be within scope of an nc and capa.Lot specific voluntary recall pfa 1757583 was initiated for the lfit v40 cocr heads within scope of this nc and 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 analyses identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.
Event or Problem Description
No new information.

• Brand Name: V40 COCR LFIT HEAD 40MM/-4
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 21971608
• Report Number: 0002249697-2025-00477
• Device Sequence Number: 12797414
• Product Code: JDI
• UDI-Device Identifier: 07613327032703
• UDI-Public: 07613327032703
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2025

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: 10/31/2012
• Device Catalogue Number: 6260-9-040
• Device Lot Number: D1EMND
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 08/05/2025; 09/02/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 08/28/2025; 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2007
• 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: 2249697-05/07/2018-003R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown