MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 2.5 ACCOLADE (127 DEG) SIZE 2.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6021-2530
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	09/02/2020
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 left hip was revised due to elevated levels of chromium and cobalt.Intra-operatively, it was observed there was no soft tissue damage and minor trunnion wear.The poly liner and head were revised to a ceramic head with sleeve and new liner.Rep provided pictures of the explants and an x-ray.Rep reported he may be able to get additional patient information and that there are no allegations against the revised liner, otherwise no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
This report is being closed as a duplicate of fda reference 0002249697-2020-01593.
Event or Problem Description
It was reported that the patient's left hip was revised due to elevated levels of chromium and cobalt.Intra-operatively, it was observed there was no soft tissue damage and minor trunnion wear.The poly liner and head were revised to a ceramic head with sleeve and new liner.Rep provided pictures of the explants and an x-ray.Rep reported he may be able to get additional patient information and that there are no allegations against the revised liner, otherwise no further information will be released by the hospital or surgeon.

• Brand Name: ACCOLADE (127 DEG) SIZE 2.5 ACCOLADE (127 DEG) 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
• MDR Report Key: 10592330
• Report Number: 0002249697-2020-01999
• Device Sequence Number: 19788089
• Product Code: LPH
• UDI-Device Identifier: 04546540510747
• UDI-Public: 04546540510747
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

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: 05/31/2016
• Device Model Number: 6021-2530
• Device Catalogue Number: 6021-2530
• Device Lot Number: 36744402
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 10/23/2020
• 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: 74 YR