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

Catalog Number	6260-9-140
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	06/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right hip was revised due to excessive trunnion wear.The stem, head and liner were revised to a new stryker liner and competitor femoral implants.Rep confirmed there were no allegations against the revised liner, and that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding wear (metallosis) involving a metal head was reported.The event was not confirmed.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted metal head.There is evidence of biological but otherwise the device is unremarkable.-clinician review: no medical records were received 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: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted metal head.There is evidence of biological but otherwise the device is unremarkable.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, and the primary/revision operative reports 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.
Additional Manufacturer Narrative
Correction: d6a.
Event or Problem Description
It was reported that the patient's right hip was revised due to excessive trunnion wear.The stem, head and liner were revised to a new stryker liner and competitor femoral implants.Rep confirmed there were no allegations against the revised liner, and that no further information will be released by the hospital or surgeon.

• Brand Name: V40 COCR LFIT HEAD 40MM/+0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 22477355
• Report Number: 0002249697-2025-00689
• Device Sequence Number: 8184609
• Product Code: JDI
• UDI-Device Identifier: 07613327032727
• UDI-Public: 07613327032727
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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: 02/28/2017
• Device Catalogue Number: 6260-9-140
• Device Lot Number: MLAJNT
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2012
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 94 KG