MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #7; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6021-0740
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's left hip was revised.As reported: "patient initially presented to clinic where he complained of pain in his left hip.X-ray revealed catastrophic failure of femoral head with femoral head dissociation.Damage to stem and cup necessitated revision of all components.All components were well fixed but explanted due to damage.Explants were not available for return.".
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving an accolade stem was reported.The event was confirmed via evaluation of the provided photographs of the stem and clinician review of the provided medical records.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs of the stem indicated damage consistent with loss of taper lock.Clinician review: a review of the provided medical information by a clinical consultant indicated: "the x-rays provided demonstrate a pressfit tha.The femoral head is dissociated and the stem trunnion is deformed with material loss.Femoral head/stem dissociation with significant damage to the trunnion is confirmed.While this event would require revision surgery no documentation of this occurring was provided.The root cause of this mechanical failure cannot be ascertained from this limited documentation." product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to disassociation of the femoral head from the stem.The reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs of the stem indicated damage consistent with loss of taper lock.A photograph of the metal head was not provided.A review of the provided medical information by a clinical consultant indicated: "the x-rays provided demonstrate a pressfit tha.The femoral head is dissociated and the stem trunnion is deformed with material loss.Femoral head/stem dissociation with significant damage to the trunnion is confirmed.The root cause of this mechanical failure cannot be ascertained from this limited documentation." further information such as device-identifying details for the metal head (catalog and lot code), photographs of the metal head, 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.H3 other text : device not returned to the manufacturer.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #7
• 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: 17124024
• Report Number: 0002249697-2023-00668
• Device Sequence Number: 20679651
• Product Code: LPH
• UDI-Device Identifier: 04546540510723
• UDI-Public: 04546540510723
• 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: 2008
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2023

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 Model Number: 6021-0740
• Device Catalogue Number: 6021-0740
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 85 YR
• Patient Sex: Male