MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 9 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6721-0937
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	07/07/2020
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.
Event or Problem Description
It was reported that the patient's right hip was revised due to aseptic loosening of the femoral stem.The patient's stem, head, and liner were revised.Rep confirmed there were no allegations against the revised head and liner, and provided the primary and revision usage.Rep can provide pictures, otherwise confirmed that no further information will be released by the hospital or surgeon.
Event or Problem Description
It was reported that the patient's right hip was revised due to aseptic loosening of the femoral stem.The patient's stem, head, and liner were revised.Rep confirmed there were no allegations against the revised head and liner, and provided the primary and revision usage.Rep can provide pictures, otherwise confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving an accolade stem was reported.The event was not confirmed.Method & results: -device evaluation and results: no product was returned for evaluation, however a photograph was provided for review.The photograph shows a recently explanted stem with the removal device still attached.Blood and tissue are visible on the stem.There is nothing remarkable visible on the photograph provided.-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: the event itself, or the exact cause of the event could not be confirmed as 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.

• Brand Name: SIZE 9 ACCOLADE II 127 DEG
• 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: 10354988
• Report Number: 0002249697-2020-01575
• Device Sequence Number: 11668570
• Product Code: LPH
• UDI-Device Identifier: 04546540669544
• UDI-Public: 04546540669544
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 10/07/2020

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: 11/30/2021
• Device Model Number: 6721-0937
• Device Catalogue Number: 6721-0937
• Device Lot Number: 57182501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 10/07/2020
• 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: 72 YR
• Patient Weight: 109