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 Code	Degraded (1153)
Health Effect - Clinical Codes	Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); Metal Related Pathology (4530)
Date of Event	09/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient called and reported; i had a stryker hip prosthesis put in around nine years ago (b)(6) 2014 and it was a recall in several countries but not necessarily our country a stryker v40, stryker accolade #2 metal on metal.I had to have it taken out and another one put in on (b)(6) 2025.I was never alerted by the doctor, hospital or stryker that there was a problem with this prosthesis and i had a pseudo tumor cyst.It took me probably a year before i realized how bad there was metal leaking into my bloodstream chromium and cobalt.I would appreciate a call back from stryker to answer some of my questions and see if we have a case to at least get reimbursement for the money that we had to put out on our own to get this redone and i mean we're not even talking about all the pain and problems we had for about a year before we realized it was what it was.Right hip.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding altr and wear/metallosis involving a metal head was reported.The event was confirmed via clinician review of the provided medical records.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 records by a clinical consultant indicated: "confirmation of event: i can confirm that the patient underwent a primary right total hip arthroplasty since i was able to review x-rays with the implant in place.I can also confirm that the patient underwent revision surgery since i was able to review the operation report.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of metallosis, elevated ion levels and trunnionosis are multifactorial including surgical technique, especially in the way the femoral head and femoral trunnion are prepared, patient factors including lifestyle, activity level and bmi, and implant factors." product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to elevated cobalt and chromium levels and altr.A review of the provided medical records by a clinical consultant indicated: "confirmation of event: i can confirm that the patient underwent a primary right total hip arthroplasty since i was able to review x-rays with the implant in place.I can also confirm that the patient underwent revision surgery since i was able to review the operation report.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of metallosis, elevated ion levels and trunnionosis are multifactorial including surgical technique, especially in the way the femoral head and femoral trunnion are prepared, patient factors including lifestyle, activity level and bmi, and implant factors." 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.Correction: a2, d6a.

• 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: 23300516
• Report Number: 0002249697-2025-01081
• Device Sequence Number: 13243333
• Product Code: JDI
• UDI-Device Identifier: 07613327032727
• UDI-Public: 07613327032727
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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: 03/31/2019
• Device Catalogue Number: 6260-9-140
• Device Lot Number: MNAAEV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2014
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 63 KG