MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM +10 OFFSET; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-336
Medical Device Problem Codes	Degraded (1153); Material Erosion (1214)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 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.
Event or Problem Description
It was reported that ¿trunnionosis of hip implant - resulting in broken implant needing to be revised surgically¿.This event was reported to stryker canada by health canada via mandatory hospital reporting: health canada reference #: (b)(4).
Additional Manufacturer Narrative
Added health canada.Ref # to h10.Reported event: an event regarding wear involving a metal head and stem was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, 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: confirmation of event: i can confirm that the patient had a left total hip arthroplasty since i was able to review and operation note, albeit undated.I have no other information except that in the product inquiry summary it states that the patient developed trunnionosis resulting in a broken implant that needed to be revised.I cannot confirm that directly since i have no office notes, revision operation report or x-rays.Root cause analysis: the root cause of trunnionosis of a hip implant resulting in a broken prosthesis needing revision in this case cannot be determined with certainty.The causes of trunnionosis with resulting fracture of a femoral stem are multifactorial including surgical technique especially in the way the trunnion and femoral head are prepared prior to insertion, patient factors including lifestyle, activity level and bmi.Implant factors can also play a role.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: a review of the provided medical records by a clinical consultant indicated: 'ii can confirm that the patient had a left total hip arthroplasty since i was able to review and operation note, albeit undated.I have no other information except that in the product inquiry summary it states that the patient developed trunnionosis resulting in a broken implant that needed to be revised.I cannot confirm that directly since i have no office notes, revision operation report or x-rays.' 'the root cause of trunnionosis of a hip implant resulting in a broken prosthesis needing revision in this case cannot be determined with certainty.The causes of trunnionosis with resulting fracture of a femoral stem are multifactorial including surgical technique especially in the way the trunnion and femoral head are prepared prior to insertion, patient factors including lifestyle, activity level and bmi.Implant factors can also play a role.' 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
It was reported that ¿trunnionosis of hip implant - resulting in broken implant needing to be revised surgically.¿ this event was reported to stryker canada by health canada via mandatory hospital reporting: health canada reference #:(b)(4).

• Brand Name: V40 COCR LFIT HEAD 36MM +10 OFFSET
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21147960
• Report Number: 0002249697-2025-00083
• Device Sequence Number: 9097506
• Product Code: JDI
• UDI-Device Identifier: 07613327032321
• UDI-Public: 07613327032321
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2025

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: 11/30/2013
• Device Catalogue Number: 6260-9-336
• Device Lot Number: MER128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2008
• 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