MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 2.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6020-2530
Medical Device Problem Codes	Degraded (1153); Material Erosion (1214)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/28/2023
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 : device not returned.
Event or Problem Description
Observed trunnionosis during total hip revision.Stem was removed and replaced with a new one.
Additional Manufacturer Narrative
Reported event: an event regarding wear involving an accolade stem that was mated with an lfit v40 cocr head was reported.The event was confirmed via evaluation of the provided photograph of the stem and clinician review of the provided medical records.Method & results: product evaluation and results: the reported device was not returned however a photograph of the stem was provided for review.Visual inspection of the provided photograph indicated that the stem is severely worn consistent with loss of taper lock.Clinician review: a review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: no medical records, pre or postoperative care or postoperative radiographs were provided for review.The pi report asserts a revision surgery but records were not provided.The x-rays do show eccentricity of the head on the trunnion presumably from trunnionosis and wear.Event confirmation: failure of the head-trunnion interface can be confirmed.Revision surgery cannot be confirmed.Increased metal levels cannot be confirmed.Root cause: while the likely failure mechanism would be corrosion at the taper, the root cause of the trunnion failure cannot be ascertained without additional medical records and examination of the implant lot numbers." 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 trunnionosis.The reported accolade stem was mated with an lfit v40 cocr head.The cocr head has been identified to be within scope of nc and capa.No further investigation for this event is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Observed trunnionosis during total hip revision.Stem was removed and replace with a new one.

• Brand Name: ACCOLADE 132 SIZE 2.5
• 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: arunabha mukherjee ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17983642
• Report Number: 0002249697-2023-01241
• Device Sequence Number: 15495558
• Product Code: LPH
• UDI-Device Identifier: 04546540510617
• UDI-Public: 04546540510617
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2023

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 Expiration Date: 08/31/2015
• Device Catalogue Number: 6020-2530
• Device Lot Number: 34490205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 11/11/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2010
• 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: 69 YR
• Patient Sex: Male