MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM +5 OFFSET; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-236
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	01/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's right hip was revised.As reported by rep: "patient started complaining a few months ago about her hip feeling abnormal.X-rays revealed a problem with the femoral head and neck combination.The trunnion was worn off.The liner was basically worn away." the head partially came off the trunnion because of the wear.
Additional Manufacturer Narrative
An event regarding disassociation involving a metal head was reported.The event was confirmed via evaluation of the provided photographs.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 and stem.Visual inspection of the photographs indicated that damage consistent with the loss of taper lock was observed on the head and stem.Material analysis, 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 a review of the device history records could not be performed as lot code information was unknown.-complaint history review: a complaint history review could not be performed as lot code information was unknown.Conclusions: as reported by rep: "patient started complaining a few months ago about her hip feeling abnormal.X-rays revealed a problem with the femoral head and neck combination.The trunnion was worn off.The liner was basically worn away.' visual inspection of the photographs indicated that damage consistent with the loss of taper lock was observed on the head and stem.Although the lot code was not provided, the device description of size and offset, the estimated date of implant and hazard/harm combination, suggests that the device is in scope of the lot specific voluntary recall pfa 1757583 which was initiated for the lfit v40 cocr heads.
Event or Problem Description
It was reported that the patient's right hip was revised.As reported by rep: "patient started complaining a few months ago about her hip feeling abnormal.X-rays revealed a problem with the femoral head and neck combination.The trunnion was worn off.The liner was basically worn away." the head partially came off the trunnion because of the wear.

• Brand Name: V40 COCR LFIT HEAD 36MM +5 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21342918
• Report Number: 0002249697-2025-00177
• Device Sequence Number: 8959587
• Product Code: JDI
• UDI-Device Identifier: 07613327032314
• UDI-Public: 07613327032314
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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 Catalogue Number: 6260-9-236
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 72 KG