MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-140
Medical Device Problem Codes	Degraded (1153); Material Erosion (1214); Noise, Audible (3273)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Metal Related Pathology (4530)
Date of Event	11/20/2025
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 reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
The following information was provided: pt.Reported; i just had a total hip revision surgery to replace the l fit anatomic v40 that apparently had been recalled.Pt.Mentioned she had been in a lot of pain with clicking and grinding.Stated that black fluid poured out when the implant was removed.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding wear and audible noise involving a metal head was reported.The event was not confirmed.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: 'i can confirm that the patient had both the primary and revision total hip arthroplasty since i was able to review x-rays with the implants in place and operation reports of each surgery.The root cause of this event cannot be determined with certainty.The causes of total hip arthroplasty failure due to trunnionosis are multifactorial, including surgical technique, patient factors including lifestyle, activity level and bmi, and implant factors.' -product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that 'pt.Reported; i just had a total hip revision surgery to replace the l fit anatomic v40 that apparently had been recalled.Pt.Mentioned she had been in a lot of pain with clicking and grinding.Stated that black fluid poured out when the implant was removed.' a review of the provided medical records by a clinical consultant indicated: 'i can confirm that the patient had both the primary and revision total hip arthroplasty since i was able to review x-rays with the implants in place and operation reports of each surgery.The root cause of this event cannot be determined with certainty.The causes of total hip arthroplasty failure due to trunnionosis are multifactorial, including surgical technique, patient factors including lifestyle, activity level and bmi, and implant factors.' the subject device has been identified to be within scope of nc and capa.Lot specific voluntary recall pfa 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.

• Brand Name: V40 COCR LFIT HEAD 40MM/+0
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23788969
• Report Number: 0002249697-2025-01458
• Device Sequence Number: 14845434
• Product Code: JDI
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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: 05/31/2014
• Device Catalogue Number: 6260-9-140
• Device Lot Number: MHHKML
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2009
• 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: Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 170 LB