MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 4.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6020-4535
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/28/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.
Event or Problem Description
In (b)(6) 2015, patient underwent a total right hip replacement using a stryker accolade tmzf 132* neck angle v40 hip stem and a trident psl ha solid black acetabular shell (56mm).Enclosed is patients operation report confirming insertion of the stryker components on (b)(6) 2015 and in (b)(6) 2021, patient returned to his orthopaedic surgeon complaining of severe pain in the left hip and groin.A few years after the procedure, patient began to experience increased pain in the right hip and returned to his surgeon for advice.Patient was informed that the hip stem had broken down and failed.Further surgery was required to insert a temporary right hip followed by a permanent right hip replacement six weeks later.As a result, patient continues to suffer from ongoing pain and disability in the right hip.

• Brand Name: ACCOLADE 132 SIZE 4.5
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16828209
• Report Number: 0002249697-2023-00436
• Device Sequence Number: 11217773
• Product Code: LPH
• UDI-Device Identifier: 04546540510631
• UDI-Public: 04546540510631
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2023

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: 11/30/2015
• Device Model Number: 6020-4535
• Device Catalogue Number: 6020-4535
• Device Lot Number: 35160305
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2010
• 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: 66 YR
• Patient Sex: Male