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

Catalog Number	6260-9-236
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and metallosis/wear involving a lfit v40 cocr head that was mated with an accolade stem was reported.The event was confirmed via provided photos.Method & results product evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted head and stem.The head was disassociated from the stem and the trunnion of the stem was penciled, resulting in the loss of taper lock between the head and the stem.The event states 'black tissue was observed', however, no image of the anatomy was provided.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 review: a review of the device history records could not be performed as no lot information was provided.Complaint history review: a complaint history review could not be performed as no lot information was provided.Conclusions: it was reported that the patient's right hip was revised due to dissociation of the head from the stem.Intra-operatively, the following were noted: the stem was notched, the trunnion was worn, and black tissue was observed.The stem, head, and liner were revised.The event was confirmed via provided photos.The reported device was not returned however photographs were provided for review.The photographs show a recently explanted head and stem.The head was disassociated from the stem and the trunnion of the stem was penciled, resulting in the loss of taper lock between the head and the stem.The event states 'black tissue was observed', however, no image of the anatomy was provided.No further investigation for this event is possible at this time.Further information such as lot details, device return, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The following information was provided: it was reported that the patient's right hip was revised due to dissociation of the head from the stem.Intra-operatively, the following were noted: the stem was notched, the trunnion was worn, and black tissue was observed.The stem, head, and liner were revised.Rep confirmed there were no allegations against the revised liner.Rep can provide pictures, otherwise confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: HEAD V40 - LFIT COCR
• 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: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 24616795
• Report Number: 0002249697-2026-00181
• Device Sequence Number: 13345778
• Product Code: JDI
• UDI-Device Identifier: 07613327032314
• UDI-Public: 07613327032314
• 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: 2015
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2026

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 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: 02/11/2026
• Initial Report FDA Received Date: 03/17/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male