MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 5.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6020-5537
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding disassociation and wear involving an accolade stem was reported.The event was confirmed based on photographs.Method & results: device evaluation and results: visual inspection: the device was not returned however photographs were provided for review.The photographs shows wear and penciling of the trunnion which breaks the lock between stem and head and there is evidence of bony ingrowth.Dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: not performed as the functional aspects are not in question.Material analysis: not performed as this event does not relate to material integrity.Medical records received and evaluation: 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: it was reported that on (b)(6) 2021 while walking the patient heard a pop and a click and began to feel pain.The event was confirmed based on inspection.Visual inspection: the device was not returned however photographs were provided for review.The photographs shows wear and penciling of the trunnion which breaks the lock between stem and head and there is evidence of bony ingrowth.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.Not returned.
Event or Problem Description
It was reported that on (b)(6) 2021 while walking the patient heard a pop and a click and began to feel pain.The patient then presented to the er and it was discovered that the head popped off the trunnion therefore a revision hip surgery was required.Total left side hip revision was performed on (b)(6) 2021.

• Brand Name: ACCOLADE 132 SIZE 5.5
• 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: 12171681
• Report Number: 0002249697-2021-01206
• Device Sequence Number: 1493293
• Product Code: LPH
• UDI-Device Identifier: 04546540510648
• UDI-Public: 04546540510648
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

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: 01/08/2013
• Device Model Number: 6020-5537
• Device Catalogue Number: 6020-5537
• Device Lot Number: 25190503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/15/2021
• 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: 73 YR