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

Catalog Number	6260-9-140
Medical Device Problem Codes	Degraded (1153); Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); Joint Laxity (4526)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: left hip revision for pain and instability.Cup, insert, screws, and head revised.Replaced with competitor cup and dual mobility with stryker head and sleeve.
Event or Problem Description
Update: additional information relating to this event was discovered through the clinician review of the provided medical records.The med review states 'loosening of an acetabular cup with spin out 16 years following the index procedure is unusual if the patient had no prior symptoms.This patient did have evidence of some black material in and around the femoral head.'.
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a metal head was reported.The event was confirmed via medical review.Method & results: -product evaluation and results: the device was not returned; however, photographs were provided for review.The photographs show a recently explanted femoral head.No conclusive determination can be made based on the photos.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: "i can confirm that the patient had a cementless total hip arthroplasty as i described above since i was able to review xrays with the implant in place.Root cause analysis: the root cause of this event cannot be determined with certainty.Loosening of an acetabular cup with spin out 16 years following the index procedure is unusual if the patient had no prior symptoms.This patient did have evidence of some black material in and around the femoral head.No trauma was reported but this could be a factor if it occurred.Surgical technique can contribute especially in the way that the femoral head and trunnion is prepared prior to insertion onto the trunnion.Patient factors including activity level, lifestyle and bmi can also play a role, as well as implant factors.N.B.Any and all explanted parts or prostheses should be submitted to stryker engineers for complete metallurgical and/or microscopic evaluation and analysis." -product history review: review of the device history records indicate the reported device was 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: a review of the provided medical records by a clinical consultant stated the following comment: "i can confirm that the patient had a cementless total hip arthroplasty as i described above since i was able to review xrays with the implant in place.Root cause analysis: the root cause of this event cannot be determined with certainty.Loosening of an acetabular cup with spin out 16 years following the index procedure is unusual if the patient had no prior symptoms.This patient did have evidence of some black material in and around the femoral head.No trauma was reported but this could be a factor if it occurred.Surgical technique can contribute especially in the way that the femoral head and trunnion is prepared prior to insertion onto the trunnion.Patient factors including activity level, lifestyle and bmi can also play a role, as well as implant factors.N.B.Any and all explanted parts or prostheses should be submitted to stryker engineers for complete metallurgical and/or microscopic evaluation and analysis." the device was not returned; however, photographs were provided for review.The photographs show a recently explanted femoral head.No conclusive determination can be made based on the photos.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.

• Brand Name: V40 COCR LFIT HEAD 40MM/+0
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24616801
• Report Number: 0002249697-2026-00177
• Device Sequence Number: 10334372
• Product Code: JDI
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2026

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: 09/30/2014
• Device Catalogue Number: 6260-9-140
• Device Lot Number: MHM1VW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2009
• 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: 2249697-05/07/2018-003R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 138 LB