MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6021-0230
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/30/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Reported event: an event regarding abnormal ion levels involving an accolade stem was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as the item was not returned.Clinician review: not performed because no medical records or x-rays were made available for evaluation.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: it was reported that the patient had excessive levels of chromium and cobalt in his blood.It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue.The event could not be confirmed, nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.Further information such as medical documentation and returned devices are needed.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.Device not returned.
Event or Problem Description
It¿s reported by the attorney, through the filing of a lawsuit, that the plaintiff underwent a left total hip arthroplasty on (b)(6) 2005 that failed and required revision on (b)(6) 2012 due to elevated levels of chromium and cobalt revealed in blood work.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #2
• 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: 10556435
• Report Number: 0002249697-2020-01934
• Device Sequence Number: 11433662
• Product Code: LPH
• UDI-Device Identifier: 04546540510679
• UDI-Public: 04546540510679
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2020

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: 04/30/2010
• Device Model Number: 6021-0230
• Device Catalogue Number: 6021-0230
• Device Lot Number: 12606304
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 09/18/2020
• 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: 84 YR