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

Model Number	6021-0537
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/28/2020
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.Device not returned.
Event or Problem Description
It was reported that the patient's right hip was revised.As reported by rep: "clicking/ unstable." rep provided the primary operative report and implant report, and pictures of the explants showing damage to the revised stem, head, and liner.Rep reported that no further information is available.
Additional Manufacturer Narrative
An event regarding wear involving an accolade stem was reported.The event was confirmed.Method & results: -device evaluation and results: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted implants with damaged stem.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: need additional information; revision operative reports, clinical and past medical history, serial dated x-rays and examination of explanted components.-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.As reported by rep: "clicking/ unstable." rep provided the primary operative report and implant report, and pictures of the explants showing damage to the revised stem, head, and liner.Rep reported that no further information is available.

• 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
• MDR Report Key: 9750364
• Report Number: 0002249697-2020-00384
• Device Sequence Number: 3029430
• Product Code: LPH
• UDI-Device Identifier: 04546540510709
• UDI-Public: 04546540510709
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2020

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 Model Number: 6021-0537
• Device Catalogue Number: 6021-0537
• Device Lot Number: 33606001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 04/08/2020
• 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: 61 YR
• Patient Weight: 121