MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 3.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6020-3535
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Reaction (2414)
Date of Event	06/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.
Event or Problem Description
It was reported that the patient's right hip was revised due to extreme wear of the trunnion and disassociation.Intra-operatively, an excessive amount of black tissue was noted in the patient.The stem, head, and poly liner were revised (rep confirmed there are no allegations against the liner).Rep provided a picture of the explants and reported that no further information is available.
Additional Manufacturer Narrative
An event regarding disassociation, wear and altr involving an accolade stem was reported.Trunnion wear was confirmed through visual analysis.Disassociation & altr were not confirmed.Method & results: device evaluation and results: visual inspection: the reported device was not returned however a photograph was provided for review.The photograph shows a recently explanted stem with trunnion wear, evidence of bony ongrowth and the presence biological matter.It is difficult to determine if the black matter is metallic debris or biological matter.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all 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 reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
It was reported that the patient's right hip was revised due to extreme wear of the trunnion and disassociation.Intra- operatively, an excessive amount of black tissue was noted in the patient.The stem, head, and poly liner were revised (rep confirmed there are no allegations against the liner).Rep provided a picture of the explants and reported that no further information is available.

• Brand Name: ACCOLADE 132 SIZE 3.5
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8785999
• Report Number: 0002249697-2019-02559
• Device Sequence Number: 19432498
• Product Code: LPH
• UDI-Device Identifier: 04546540510624
• UDI-Public: 04546540510624
• 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 Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2019

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: 06/30/2015
• Device Catalogue Number: 6020-3535
• Device Lot Number: 33740103
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 09/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR