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

Model Number	6020-0230
Medical Device Problem Codes	Degraded (1153); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Inflammation (1932); Metal Related Pathology (4530)
Date of Event	10/13/2020
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 left hip was revised due to gross trunnion failure.The femoral head was reported to be toggling on the worn down trunnion, and black tissue was noted.The patient's entire hip construct was revised in order for the surgeon to clear all metal debris from the joint.The rep can provide additional pictures and reported that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Corrected data: it was discovered that the selection for b2 was inadvertently missed during the submission of the initial report.B2 has been updated with the appropriate information.Investigation complete.Reported event: an event regarding fretting involving an accolade stem was reported.The event was confirmed.Based on provided photos.Method & results: device evaluation and results: material analysis, functional and dimensional inspections could not be performed as the device was not returned.Visual inspection - as per the provided photos, it shows to be recently explanted with blood tissues and blood on them.Also, dark colored tissue shown on it and signs of trunnion wear are noticed on the stem.Clinical review: no medical records were received for review with a clinical consultant.   product history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusion: an event regarding fretting involving an accolade stem was reported.The event was confirmed.Based on provided photos.As per the provided photos, it shows to be recently explanted with blood tissues and blood on them.Also, dark colored tissue shown on it and signs of trunnion wear are noticed on the stem.The exact cause of the event could not be determined because insufficient medical information was provided.Further information such as more medical documentation, patient history, demographics are needed.If additional information are received, this investigation will be reopened and re-evaluated.
Event or Problem Description
It was reported that the patient's left hip was revised due to gross trunnion failure.The femoral head was reported to be toggling on the worn down trunnion, and black tissue was noted.The patient's entire hip construct was revised in order for the surgeon to clear all metal debris from the joint.The rep can provide additional pictures and reported that no further information will be released by the hospital or surgeon.

• Brand Name: ACCOLADE 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: 10799892
• Report Number: 0002249697-2020-02355
• Device Sequence Number: 1137949
• Product Code: LPH
• UDI-Device Identifier: 04546540510549
• UDI-Public: 04546540510549
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021

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: 6020-0230
• Device Catalogue Number: 6020-0230
• Device Lot Number: 23935201
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 01/04/2021
• 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: 60 YR
• Patient Weight: 73