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 Codes	Degraded (1153); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	11/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Disassembly of the prosthetic implant on (b)(6) 2021, worn.Operated on (b)(6) 2021.Very severe metallosis with "pseudotumor"; wear of the femoral collar.Stem and head explanted and re-implantation of new components.
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Catalog numbers and lot codes of other devices listed in this report: cat # mmh-9988-0048, lot # fm61492, description: mitch trh md hd sz 48+0, manufacturer: depuy.Device evaluated by manufacturer? not returned to the manufacturer.

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13153112
• Report Number: 0002249697-2022-00012
• Device Sequence Number: 14472845
• Product Code: LPH
• UDI-Device Identifier: 04546540510679
• UDI-Public: 04546540510679
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 01/04/2022

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: 03/31/2013
• Device Model Number: 6021-0230
• Device Catalogue Number: 6021-0230
• Device Lot Number: 25866405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 60
• Patient Sex: Unknown