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	Material Erosion (1214); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	03/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.H3 other text : not returned to the manufacturer.
Event or Problem Description
It was reported that the "patient arrived in clinic with obvious component failure on x-ray.Felt hip let go.X-rays from (b)(6)2023 showed evidence of start of failure.The x-ray showing full failure was taken on (b)(6) 2024.".
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and wear involving an accolade stem was reported.The event was confirmed via provided photographs of the devices and clinician review of the provided medical records.Method & results: -product evaluation and results: the reported devices were not returned; however, photographs were provided for review.The photographs show severe wear of the stem trunnion consistent with loss of taper lock.-clinician review: a review of the provided medical information by a clinical consultant indicated: "confirmation of event: i can confirm that the patient had a total hip arthroplasty total hip arthroplasty since i was able to see an x-ray both with impending catastrophic failure and full catastrophic failure.I cannot confirm the explantation because i have no documentation such as the surgeon's notes, operation reports, or post revision x-rays.Root cause analysis: the root cause of this event cannot be determined with certainty.The root causes of catastrophic trunnion failure with head neck disassociation are multifactorial including surgical technique factors, importantly the way that the femoral head and trunnion are prepared prior to and during insertion.Patient factors can also contribute including the patient's lifestyle, activity level and bmi.Implant factors can also possibly contribute." -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.The reported devices were not returned; however, photographs were provided for review.The photographs show severe wear of the stem trunnion consistent with loss of taper lock.The event was further confirmed via review of the provided medical records by a clinical consultant: "i can confirm that the patient had a total hip arthroplasty total hip arthroplasty since i was able to see an x-ray both with impending catastrophic failure and full catastrophic failure.[.] root cause analysis: the root cause of this event cannot be determined with certainty.The root causes of catastrophic trunnion failure with head neck disassociation are multifactorial including surgical technique factors, importantly the way that the femoral head and trunnion are prepared prior to and during insertion.Patient factors can also contribute including the patient's lifestyle, activity level and bmi.Implant factors can also possibly contribute." 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 that the "patient arrived in clinic with obvious component failure on x-ray.Felt hip let go.X-rays from (b)(6) 2023 showed evidence of start of failure.The x-ray showing full failure was taken on (b)(6) 2024.".

• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19037611
• Report Number: 0002249697-2024-00548
• Device Sequence Number: 15462797
• Product Code: LPH
• UDI-Device Identifier: 04546540510761
• UDI-Public: 04546540510761
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

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: 10/31/2017
• Device Catalogue Number: 6021-4535
• Device Lot Number: 41686501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2012
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 96 KG
• Patient Race: American Indian Or Alaskan Native