MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6021-0537
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Joint Dislocation (2374); Metal Related Pathology (4530)
Date of Event	01/18/2024
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 other similar events for the lot referenced.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
It was reported through the filing of a lawsuit that allegedly the patient underwent right tha on (b)(6) 2011, and was implanted with an lfit anatomic cocr v40 femoral head and an accolade tmzf hip stem and was revised on (b)(6) 2024.It is further alleged that he suffered injuries as a result of implantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation & abnormal ion level involving accolade stem was reported.The event for disassociation was confirmed via medical review.Method & results: product evaluation and results: the reported device was not returned but photos were provided for review.The photos show a recently explanted femoral stem with signs of trunnion wear.Clinical review: summary: this product inquiry concerns a male patient who underwent a cementless right total hip arthroplasty with a trident cup and accolade tmzf femoral stem with a cobalt chrome lfit femoral head coupled with an x3 acetabular liner.The date of implant was (b)(6) 2011.The patient developed head neck disassociation with elevated ion levels and underwent revision surgery on (b)(6) 2024.A competitor femoral stem was utilized.I can confirm that the patient underwent the primary.Confirmation of event: i can confirm that the patient had the primary total hip arthroplasty since i was able to review the original operation report and the x-rays showing the failed implant.I can also confirm that the patient underwent revision surgery since i was able to review the revision operation report.I was not supplied with any post revision x-rays.Root cause analysis: the root cause of this event cannot be determined with certainty.Causes of head neck disassociation, failure of the trunnion and elevated metal ion levels are multifactorial.These causes include surgical technique, especially in the way of preparation and insertion of the femoral head onto the trunnion at the initial primary procedure.Importantly, there was no mention of any preparation whatsoever in the primary operation report.Also contributing are patient factors including activity level and bmi, and also implant factors.Product history review: review of the product history records indicate devices were manufactured and accepted into final stock with no reported relevant discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the reported accolade stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of an nc and capa.A review of the provided medical records by a clinical consultant stated the following comment: "i can confirm that the patient had the primary total hip arthroplasty since i was able to review the original operation report and the x-rays showing the failed implant.I can also confirm that the patient underwent revision surgery since i was able to review the revision operation report.I was not supplied with any post revision x-rays.Root cause analysis: the root cause of this event cannot be determined with certainty.Causes of head neck disassociation, failure of the trunnion and elevated metal ion levels are multifactorial.These causes include surgical technique, especially in the way of preparation and insertion of the femoral head onto the trunnion at the initial primary procedure.Importantly, there was no mention of any preparation whatsoever in the primary operation report.Also contributing are patient factors including activity level and bmi, and also 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.
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly the patient underwent right tha on (b)(6) 2011, and was implanted with an lfit anatomic cocr v40 femoral head and an accolade tmzf hip stem and was revised on (b)(6) 2024.It is further alleged that he suffered injuries as a result of implantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 19360194
• Report Number: 0002249697-2024-00772
• Device Sequence Number: 6500690
• Product Code: LPH
• UDI-Device Identifier: 04546540510709
• UDI-Public: 04546540510709
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2024

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: 04/30/2016
• Device Catalogue Number: 6021-0537
• Device Lot Number: 36584206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2011
• 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: 65 YR
• Patient Sex: Male