MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6020-0335
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Reaction (2414)
Date of Event	08/14/2019
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.Should additional information become available, 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 trunnionosis.Intra-operatively, black material was noted inside the femoral head.A 36 -5 lfit v40 head and poly liner were revised to a biolox head with sleeve and poly liner.The stem was not revised, and rep confirmed that there are no allegations against the liner.Rep has some pictures to provide and can return the explants, and reported that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding fretting involving an accolade stem was reported.The event was not confirmed.Method & results: device evaluation and results: the reported device was not returned however photographs were provided for review.The photographs show black debris around the stem and black debris on the head most likely caused by fretting.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: no further investigation for this event is possible at this time as no devices was received by stryker orthopaedics.If devices become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's right hip was revised due to trunnionosis.Intra-operatively, black material was noted inside the femoral head.A 36 -5 lfit v40 head and poly liner were revised to a biolox head with sleeve and poly liner.The stem was not revised and rep confirmed that there are no allegations against the liner.Rep has some pictures to provide and can return the explants, and reported that no further information will be released by the hospital or surgeon.

• Brand Name: ACCOLADE TMZF HIP STEM #3
• 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: 8984139
• Report Number: 0002249697-2019-03169
• Device Sequence Number: 2922178
• Product Code: LPH
• UDI-Device Identifier: 04546540510556
• UDI-Public: 04546540510556
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 11/20/2019

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: 06/30/2020
• Device Catalogue Number: 6020-0335
• Device Lot Number: 52050805
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 11/20/2019
• 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: 69 YR