MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6020-0230
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right hip was revised due to head dissociation.Intra-operatively, excessive wear was noted of the trunnion.The stem, head and liner were revised to a competitor stem, head, and dual mobility poly with a stryker mdm liner.Rep confirmed that there were no allegations against the revised liner, and that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and wear involving an accolade stem was reported.The events was confirmed via med review and review of the provided photographs.Method & results: product evaluation and results: visual inspection: the device was not returned; however, photographs were provided for review.The photographs show a recently explanted stem with an extremely worn trunnion.Clinician review: a review of the provided medical information by a clinical consultant indicated: "i can confirm that the patient underwent a primary total hip arthroplasty as described above since i was able to review and x-ray showing the implant.I can also confirm that the patient's developed a head neck disassociation with loss of material on the trunnion also because i was able to see the explanted prosthesis.Some blackened material was also noted within the bore of the femoral head.The root causes of head neck disassociation with loss of material of the trunnion and blackened material within the border of the femoral head are multifactorial including surgical technique, especially in the preparation and insertion of the femoral head onto the trunnion, patient factors including activity level and bmi, and implant factors."-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 femoral head from the stem.The device was not returned; however, photographs were provided for review.The photographs show a recently explanted stem with an extremely worn trunnion.A review of the provided medical information by a clinical consultant indicated: "i can confirm that the patient underwent a primary total hip arthroplasty as described above since i was able to review and x-ray showing the implant.I can also confirm that the patient's developed a head neck disassociation with loss of material on the trunnion also because i was able to see the explanted prosthesis.Some blackened material was also noted within the bore of the femoral head.The root causes of head neck disassociation with loss of material of the trunnion and blackened material within the border of the femoral head are multifactorial including surgical technique, especially in the preparation and insertion of the femoral head onto the trunnion, patient factors including activity level and bmi, and implant factors." 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.

• Brand Name: ACCOLADE TMZF HIP STEM #2
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19018507
• Report Number: 0002249697-2024-00541
• Device Sequence Number: 12801050
• Product Code: LPH
• UDI-Device Identifier: 04546540510549
• UDI-Public: 04546540510549
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2024

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: 10/31/2012
• Device Catalogue Number: 6020-0230
• Device Lot Number: 24392904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2007
• 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: Female
• Patient Weight: 64 KG