MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +4 V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-5-232
Medical Device Problem Codes	Corroded (1131); Material Erosion (1214); Loss of Osseointegration (2408)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's right hip was revised due to pain and superior lucency around the acetabular screws.Intra-operatively, the following were noted: some tissue staining, corrosion inside of the femoral head (no corrosion or wear was noted on the trunnion), and once the screws were removed, the shell came out easily.The head, liner, shell, and screws were revised.Rep confirmed there are no allegations against the revised liner.Rep can provide pictures and otherwise confirmed that no further information will be released by the hospital or surgeon.
Event or Problem Description
It was reported that the patient's right hip was revised due to pain and superior lucency around the acetabular screws.Intra-operatively, the following were noted: some tissue staining, corrosion inside of the femoral head (no corrosion or wear was noted on the trunnion), and once the screws were removed, the shell came out easily.The head, liner, shell, and screws were revised.Rep confirmed there are no allegations against the revised liner.Rep can provide pictures and otherwise confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding corrosion involving a metal head was reported.The event was not confirmed.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs indicated that the recently explanted device is covered in blood and an unidentified black liquid material.Given the quality of the photographs and the shadow covering the inside of the head, it is difficult to make any conclusion regarding identification of the black material.Scratches and additional damage consistent with the explantation attempt are also observed.The corrosion event is not confirmed.-clinician review: a review of the provided medical information by a clinical consultant indicated: "materials reviewed: 11/16/2021: stryker report undated/unlabeled: x-ray ap right hip.Stable appearing tha with uncemented components and two screws in the shell.No obvious loosening.Undated/unlabeled: x-ray ap right hip.Similar or same implants now with some lucency at the superior lateral periphery of the shell and likely lytic changes medial to the shell.Confirmation: some lucency can be confirmed around the acetabulum, but no other aspects of the event may be confirmed without additional medical information and history.Root cause: a root cause cannot be determined as the events cannot be confirmed." -product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that the patient was revised and "corrosion inside of the femoral head" was observed intraoperatively.Visual inspection of photographs of the device indicated the presence of foreign matter on the inside of the head but it could not be confirmed from the photograph that the material was corrosive in nature.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, additional pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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: 32MM +4 V40 TAPER VIT HEAD
• 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 NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12980523
• Report Number: 0002249697-2021-02045
• Device Sequence Number: 17322208
• Product Code: JDI
• UDI-Device Identifier: 07613327012903
• UDI-Public: 07613327012903
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K993601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2022

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: 04/30/2010
• Device Model Number: 6260-5-232
• Device Catalogue Number: 6260-5-232
• Device Lot Number: 13060001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2005
• 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: 57 YR
• Patient Sex: Female