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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding abnormal ion level involving an accolade stem was reported.The event was not confirmed.Method & results:  device evaluation and results: not performed as device was not received.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 was not confirmed as insufficient information was provided.Further information such as device return, pre and post operative x-rays, operative reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Device not returned.
Event or Problem Description
It was reported that the patient's left hip was revised due to elevated chromium levels (reported to the rep as "80").An accolade stem, v40 cocr l-fit head, and liner were revised with no allegations against the liner.Rep reported that pictures are available, but otherwise no further information will be released by the hospital or surgeon.

• 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: 12127251
• Report Number: 0002249697-2021-01145
• Device Sequence Number: 3428194
• Product Code: LPH
• UDI-Device Identifier: 04546540510709
• UDI-Public: 04546540510709
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/07/2021

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: 09/30/2012
• Device Model Number: 6021-0537
• Device Catalogue Number: 6021-0537
• Device Lot Number: 23745601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 07/07/2021
• 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: 89 YR
• Patient Weight: 75