MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6021-4535
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
Additional Manufacturer Narrative
Reported event: an event regarding disassociation & wear involving an accolade stem that was mated with a lfit v40 cocr head was reported.The event was not confirmed.Method & results: -device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: 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 (b)(6) 2024.He underwent revision surgery on (b)(6) 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." -device 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.Conclusion: it was reported that the patient was revised due to disassociation.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 (b)(6) 2024.He underwent revision surgery on (b)(6) 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 reported accolade stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of nc and capa.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) 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.

• Brand Name: ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 19802725
• Report Number: 0002249697-2024-01011
• Device Sequence Number: 7524704
• Product Code: LPH
• UDI-Device Identifier: 04546540510761
• UDI-Public: 04546540510761
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K994366
• 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
• 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: 09/30/2011
• Device Catalogue Number: 6021-4535
• Device Lot Number: 20131101
• 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: 09/26/2006
• 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: 82 YR
• Patient Sex: Male