MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6021-0335
Medical Device Problem Codes	Material Erosion (1214); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	01/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
As reported by the rep: revision was performed.
Additional Manufacturer Narrative
An event regarding disassociation and wear involving an accolade stem was reported.The event was confirmed via clinician review of the provided medical records.Method & results: product 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 information by a clinical consultant indicated: "confirmation of event: i can confirm that the patient underwent a primary right total hip arthroplasty on (b)(6) 2012 since i was able to see a translation of the operation report.I can also confirm that the patient underwent a revision procedure on (b)(6) 2024 again since i was able to see a translation of the operation report.Root cause analysis: the root cause of this event cannot determined with certainty.Causes of head neck disassociation, metallosis and trunnionosis are multifactorial.These causes include surgical technique, especially in the preparation and insertion of the femoral head onto the trunnion.No mention was made of any preparation in this particular case." 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.Metallosis was also reported.The event was confirmed via review of the provided medical records by a clinical consultant: "i can confirm that the patient underwent a primary right total hip arthroplasty on (b)(6) 2012 since i was able to see a translation of the operation report.I can also confirm that the patient underwent a revision procedure on (b)(6) 2024 again since i was able to see a translation of the operation report.[.] the root cause of this event cannot determined with certainty.Causes of head neck disassociation, metallosis and trunnionosis are multifactorial.These causes include surgical technique, especially in the preparation and insertion of the femoral head onto the trunnion.No mention was made of any preparation in this particular case." 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
As reported by the rep: revision was performed.Update per medical records: the patient was revised due to disassociation of the metal head from the stem.Severe wearing of the stem trunnion also resulted in metallosis.Right hip.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #3
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18683979
• Report Number: 0002249697-2024-00216
• Device Sequence Number: 15261063
• Product Code: LPH
• UDI-Device Identifier: 04546540510686
• UDI-Public: 04546540510686
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2024

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: 08/31/2017
• Device Catalogue Number: 6021-0335
• Device Lot Number: 40844501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2012
• 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 Age: 68 YR
• Patient Sex: Male