MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah V40 COCR LFIT HEAD 36MM 0 OFFSET; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Catalog Number	6260-9-136
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	06/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: it was reported through the filing of a lawsuit that allegedly the patient underwent right tha on november 14, 2013, and was implanted with an lfit v40 femoral head.It is alleged he developed increasing hip pain, elevated cobalt levels, mri findings demonstrating a fluid collection and possible pseudotumor and findings concerning for metallosis.He was revised on june 21, 2024.
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

• Brand Name: V40 COCR LFIT HEAD 36MM 0 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50880647
• Report Number: 0002249697-2026-00883
• Device Sequence Number: 18589732
• Product Code: JDI
• UDI-Device Identifier: 07613327032307
• UDI-Public: 07613327032307
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 10/31/2018
• Device Catalogue Number: 6260-9-136
• Device Lot Number: MMNW4D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2013
• 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: Required Intervention; Hospitalization
• Patient Sex: Male