MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6020-0130
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Metal Related Pathology (4530)
Date of Event	08/29/2024
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.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.
Event or Problem Description
As reported by the rep: "it was a combination of an accolade 1 stem and cocr +head.It looks like the patient is potentially looking to check/pursue any incompatibility as they experienced metallosis.I have forwarded the hip composition guide.Right hip; event was noticed via mri done at clinic which showed pseudotumor and elevated metal ion levels.Elevated metal ion levels (both cobalt and chromium elevated) post primary surgery.During revision surgery, trunnionosis was noted.".
Event or Problem Description
As reported by the rep: "it was a combination of an accolade 1 stem and cocr +head.It looks like the patient is potentially looking to check/pursue any incompatibility as they experienced metallosis.I have forwarded the hip composition guide.Right hip: event was noticed via mri done at clinic which showed pseudotumor and elevated metal ion levels.Elevated metal ion levels (both cobalt and chromium elevated) post primary surgery.During revision surgery, trunnionosis was noted.".
Additional Manufacturer Narrative
Reported event: an event regarding altr/abnormal ion level and wear involving a accolade stem was reported.The event was not confirmed.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 with a clinical consultant indicated "confirmation of event: i can confirm that the patient had a right primary cementless total hip arthroplasty since i was able to see an x-ray pre-revision with the implant in place.I can also confirm the revision surgery since i was able to review the operation report and the post revision xrays.I cannot confirm elevated metal ion levels because there was no documentation for this except on the product inquiry summary.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of pseudo-tumor, presumably with trunnionosis, and trunnion wear, are multifactorial including surgical technique especially in the way the femoral head and femoral trunnion is prepared and inserted.Also possible contributors are patient factors such as lifestyle, activity level and bmi, as well as 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: a review with a clinical consultant indicated "confirmation of event: i can confirm that the patient had a right primary cementless total hip arthroplasty since i was able to see an x-ray pre-revision with the implant in place.I can also confirm the revision surgery since i was able to review the operation report and the post revision xrays.I cannot confirm elevated metal ion levels because there was no documentation for this except on the product inquiry summary.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of pseudo-tumor, presumably with trunnionosis and trunnion wear, are multifactorial including surgical technique especially in the way the femoral head and femoral trunnion is prepared and inserted.Also possible contributors are patient factors such as lifestyle, activity level and bmi, as well as 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.

• Brand Name: ACCOLADE TMZF HIP STEM #1
• 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: 20285785
• Report Number: 0002249697-2024-01315
• Device Sequence Number: 18139536
• Product Code: LPH
• UDI-Device Identifier: 04546540510532
• UDI-Public: 04546540510532
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K994366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: 03/31/2015
• Device Catalogue Number: 6020-0130
• Device Lot Number: 32824602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2010
• 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: 70 YR
• Patient Sex: Female