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	Migration (4003)
Health Effect - Clinical Codes	Joint Laxity (4526); Insufficient Information (4580)
Date of Event	08/17/2020
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.
Event or Problem Description
Revision right tha.Femoral stem subsidence.
Additional Manufacturer Narrative
An event regarding subsidence involving an accolade stem was reported.The event was confirmed by clinician review.Method & results: device evaluation and results: the device not returned.Visual inspection of the received image of the explants noted stem covered in blood stains, nothing remarkable observed.Dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: the available medical records were provided to the consulting clinician for a review which noted that, " no clinical or pmh, no operative reports, no dated serial x-rays, no examination of explanted components.While the submitted x-ray appears to confirm the event description, insufficient information is available to create a medical report for this case." 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.Conclusion: it was reported that the patient was revised due to femoral subsidence.The available medical records were provided to the consulting clinician for a review which noted that no clinical or pmh, no operative reports, no dated serial x-rays, no examination of explanted components.While the submitted x-ray appears to confirm the event description, insufficient information is available to create a medical report for this case.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.
Event or Problem Description
Revision right tha.Femoral stem subsidence.

• 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: 10556439
• Report Number: 0002249697-2020-01932
• Device Sequence Number: 2683029
• Product Code: LPH
• UDI-Device Identifier: 04546540510709
• UDI-Public: 04546540510709
• 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: 2011
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020

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: 11/30/2012
• Device Model Number: 6021-0537
• Device Catalogue Number: 6021-0537
• Device Lot Number: 24631403
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 11/12/2020
• 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: 75 YR
• Patient Weight: 95