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

Catalog Number	6260-9-232
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	05/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event an event regarding corrosion and wear involving a metal head was reported.The event was not confirmed.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinical review: no medical records were received for review with a clinical consultant.-product history review: review of the product history records indicate devices were manufactured and accepted into final stock with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports and the revision 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.
Event or Problem Description
It was reported by patient's counsel as a result of a legal claim that allegedly the patient underwent right tha on (b)(6) 2016, and was implanted with an lfit v40 cocr femoral head and accolade ii hip stem requiring revision surgery on (b)(6) 2021, due to alleged metallosis and corrosion.

• Brand Name: 32MM +4 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19495772
• Report Number: 0002249697-2024-00855
• Device Sequence Number: 18279217
• Product Code: JDI
• UDI-Device Identifier: 07613327013085
• UDI-Public: 07613327013085
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/09/2024

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: 04/30/2021
• Device Catalogue Number: 6260-9-232
• Device Lot Number: 55178001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 06/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2016
• 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: Female