MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM STD LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-9-132
Medical Device Problem Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Metal Related Pathology (4530)
Date of Event	10/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's left hip was revised due to pseudotumor and elevated cobalt and chrome levels.Intra-operatively, black debris was noted on the trunnion after the well-fixed femoral head was removed.The head and liner were revised.Rep confirmed that there are no allegations against the revised liner.Rep also reported that pictures and revision usage can be provided, and that no further information will be released by the hospital or surgeon.
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 left hip was revised due to pseudotumor and elevated cobalt and chrome levels.Intra-operatively, black debris was noted on the trunnion after the well-fixed femoral head was removed.The head and liner were revised.Rep confirmed that there are no allegations against the revised liner.Rep also reported that pictures and revision usage can be provided, and that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding altr and abnormal ion levels involving a metal head was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection: the device was not returned but photographs were provided for review.The photographs noted black debris around metal head.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: no medical records were received for review with a clinical consultant.-device history review: indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there has been no other event for the lot referenced.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: 32MM STD LFIT V40 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 12833571
• Report Number: 0002249697-2021-01926
• Device Sequence Number: 4434455
• Product Code: JDI
• UDI-Device Identifier: 07613327013047
• UDI-Public: 07613327013047
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2022

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: 01/31/2010
• Device Model Number: 6260-9-132
• Device Catalogue Number: 6260-9-132
• Device Lot Number: 11838805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2005
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 106 KG