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

Catalog Number	6260-9-240
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	10/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by counsel that claimant underwent right tha on (b)(6) 2009 and was implanted with an lfit anatomic v40 femoral head and accolade tmzf stem.She was revised on (b)(6) 2022, and allegedly the trunnion was grossly worn.
Additional Manufacturer Narrative
Reported event: an event regarding wear involving an unknown metal head 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: no medical records were received for review with a clinical consultant.-product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
An event regarding disassociation involving an metal head was reported.The event was confirmed as this device lot was identified to be within scope of the capa.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 underwent the primary and revision procedures since i was able to review the operation report reports.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of trunnionosis with metallosis and head neck disassociation are multifactorial including surgical technique, especially in the way that the femoral head and trunnion are prepared prior to insertion, patient factors including lifestyle, activity level and bmi, and implant factors.In this case there was no particular preparation of the head and trunnion prior to insertion of the final components in the primary operation report.' -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: a review of the provided medical records by a clinical consultant indicated: 'confirmation of event: i can confirm that the patient underwent the primary and revision procedures since i was able to review the operation report reports.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of trunnionosis with metallosis and head neck disassociation are multifactorial including surgical technique, especially in the way that the femoral head and trunnion are prepared prior to insertion, patient factors including lifestyle, activity level and bmi, and implant factors.In this case there was no particular preparation of the head and trunnion prior to insertion of the final components in the primary operation report.' the subject device has been identified to be within scope of an nc and capa.Lot specific voluntary recall ra 2016-028 was initiated for the lfit v40 cocr heads within scope of said 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.

• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21315305
• Report Number: 0002249697-2025-00145
• Device Sequence Number: 8213995
• Product Code: JDI
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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: 02/28/2014
• Device Catalogue Number: 6260-9-240
• Device Lot Number: MHKPMA
• 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): Follow-Up
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2009
• 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: 2249697-08/29/2016-007R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female