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 Codes	Degraded (1153); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Date of Event	05/24/2024
Type of Reportable Event	Serious Injury
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) 2007 and was implanted with an lfit v40 femoral head and accolade stem requiring revision surgery on (b)(6) 2024, due to alleged broken trunnion.The surgeon ¿encountered dark joint fluid and heavily pigmented tissue consistent with metallosis".
Additional Manufacturer Narrative
Reported event: an event regarding disassociation & 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.-medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: "a patient underwent a primary total hip arthroplasty for right hip arthritis.The procedure was routine per the operative report.Pre and postoperative medical information and radiographs were not provided for review.No data on the ensuing history were provided for review prior to a revision hip arthroplasty.The patient apparently had a nontraumatic pop and subsequent fall, the date was not defined, but he presented on 05/17/2024.He underwent revision surgery on 05/24/2024.At the time of surgery, metallosis was described as well as disassociation of the femoral head from the trunnion, and severe trunnion damage.The trunnion was described as "broken".A new liner was placed, an mdm, and a new competitive femoral stem placed.The postoperative results, medical history, and radiographs were not provided for review.Event confirmation: a primary right hip arthroplasty with stryker components can be confirmed.A revision hip arthroplasty can be confirmed.The surgeon¿s dictated findings were of a "broken trunnion" and intraoperative findings were consistent with metallosis and disassociation of the femoral head from the trunnion.Radiographs or pathologic specimen examination were not provided for confirmation of the surgeon's findings.Root cause: the root cause of the primary hip arthroplasty was hip arthritis.The root cause of the revision surgery appeared to be disassociation of the femoral head from a severely worn trunnion." -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 due to disassociation of the head from the stem.A review of the provided medical records by a clinical consultant indicated: "a patient underwent a primary total hip arthroplasty for right hip arthritis.The procedure was routine per the operative report.Pre and postoperative medical information and radiographs were not provided for review.No data on the ensuing history were provided for review prior to a revision hip arthroplasty.The patient apparently had a nontraumatic pop and subsequent fall, the date was not defined, but he presented on 05/17/2024.He underwent revision surgery on 05/24/2024.At the time of surgery, metallosis was described as well as disassociation of the femoral head from the trunnion, and severe trunnion damage.The trunnion was described as "broken".A new liner was placed, an mdm, and a new competitive femoral stem placed.The postoperative results, medical history, and radiographs were not provided for review.Event confirmation: a primary right hip arthroplasty with stryker components can be confirmed.A revision hip arthroplasty can be confirmed.The surgeon¿s dictated findings were of a "broken trunnion" and intraoperative findings were consistent with metallosis and disassociation of the femoral head from the trunnion.Radiographs or pathologic specimen examination were not provided for confirmation of the surgeon's findings.Root cause: the root cause of the primary hip arthroplasty was hip arthritis.The root cause of the revision surgery appeared to be disassociation of the femoral head from a severely worn trunnion." the subject device has been identified to be within scope of nc and capa.Lot specific voluntary recall pfa 1757583 was initiated for the lfit v40 cocr heads within scope of nc and capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before march 4, 2011.The root cause analyses identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.

• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19800333
• Report Number: 0002249697-2024-01012
• Device Sequence Number: 8388919
• Product Code: JDI
• UDI-Device Identifier: 07613327032307
• UDI-Public: 07613327032307
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K022077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/22/2024

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: 06/30/2010
• Device Catalogue Number: 6260-9-136
• Device Lot Number: 30264503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2005
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2249697-05/07/2018-003R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Male