MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-340
Medical Device Problem Codes	Degraded (1153); Material Erosion (1214); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Metal Related Pathology (4530)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by counsel that claimant underwent right tha on (b)(6) 2013 and was implanted with an lfit anatomic v40 femoral head and #5 accolade tmzf stem.Allegedly she developed metallosis about the hip and has fractured her femoral head off of the trunnion.She was revised on (b)(6) 2024.
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.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation & wear involving a metal head was reported.The events was confirmed through medical review.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 information by a clinical consultant indicated: conclusion/assessment: no medical records were provided for review.No postoperative revision films or pre-claim x-rays were provided for review.The pi report notes a revision for metallosis and implant failure.The x-rays do show disassociation of a large metallic head from a tmzf stem.Event confirmation: failure of a v40-accolade tmzf stem combination can be confirmed.Xrays show a head disarticulating from the stem.A revision cannot be confirmed but would be expected.Root cause: the root cause for the unconfirmed revision would be disarticulation of the head from the stem.The root cause of the implant failure would be trunnionosis and failure at the head neck junction.The root cause of the trunnionosis cannot be ascertained without additional information -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: it was reported by counsel that claimant underwent right tha on december 26, 2013 and was implanted with an lfit anatomic v40 femoral head and #5 accolade tmzf stem.Allegedly she developed metallosis about the hip and has fractured her femoral head off of the trunnion.She was revised on (b)(6) 2024.A review of the provided medical information by a clinical consultant indicated:' no medical records were provided for review.No postoperative revision films or pre-claim x-rays were provided for review.The pi report notes a revision for metallosis and implant failure.The x-rays do show disassociation of a large metallic head from a tmzf stem.' 'failure of a v40-accolade tmzf stem combination can be confirmed.Xrays show a head disarticulating from the stem.A revision cannot be confirmed but would be expected.''the root cause for the unconfirmed revision would be disarticulation of the head from the stem.The root cause of the implant failure would be trunnionosis and failure at the head neck junction.The root cause of the trunnionosis cannot be ascertained without additional information'.Further information such as return of the device, 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
It was reported by counsel that claimant underwent right tha on december (b)(6) 2013 and was implanted with an lfit anatomic v40 femoral head and #5 accolade tmzf stem.Allegedly she developed metallosis about the hip and has fractured her femoral head off of the trunnion.She was revised on (b)(6) 2024.

• Brand Name: V40 COCR LFIT HEAD 40MM/+8
• 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: 21321405
• Report Number: 0002249697-2025-00156
• Device Sequence Number: 12742086
• Product Code: JDI
• UDI-Device Identifier: 07613327032765
• UDI-Public: 07613327032765
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• 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: 07/31/2018
• Device Catalogue Number: 6260-9-340
• Device Lot Number: MMJKW7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2013
• 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: 61 YR
• Patient Sex: Female