MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 FEM HEAD ORTHINOX 26-0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6364-2-126
Medical Device Problem Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Primary surgery, artificial head replacement surgery, was performed 12 years before.Revision surgery was performed due to a problem on the acetabular side.It was found that removed stem with black stain on medial portion of stem.
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
Primary surgery, artificial head replacement surgery, was performed 12 years before.Revision surgery was performed due to a problem on the acetabular side.It was found that removed stem with black stain on medial portion of stem.
Additional Manufacturer Narrative
Reported event: an event regarding revision involving a metal head was reported.The event for revision was confirmed.Method & results: -device evaluation and results: visual inspection of the returned device indicated that explantation damage was observed.-clinician review: no medical records were received for review with a clinical consultant.-device history review: a review of the device history records indicates devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: it was reported that the patient was revised.Visual inspection of the returned device indicated that explantation damage was observed.The reason for revision was not clearly stated.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: V40 FEM HEAD ORTHINOX 26-0
• 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-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20665618
• Report Number: 0002249697-2024-01542
• Device Sequence Number: 8207764
• Product Code: JDI
• UDI-Device Identifier: 04546540273314
• UDI-Public: 04546540273314
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2025

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 Expiration Date: 02/28/2014
• Device Catalogue Number: 6364-2-126
• Device Lot Number: G2691022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2009
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 49 KG