MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL WITH PUREFIX HA 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	542-11-54F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	08/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding osteolysis involving a trident shell was reported.The event was reported and confirmed via clinician review.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following: adverse event identified: revision of left hip arthroplasty due to disassociation of a femoral head from a tmzf stem and trunnionosis.Hazards: failure of trunnion-head construct.Conclusion of assessment: review of the records provided confirmed the implant disassociation and trunnion wear.Review of implant stickers could define if the head was an lfit or associated with an lfit problem.Obtaining the implant may provide additional insight into the mechanism of disassociation.Product history review: not performed as the device lot details were not provided.Complaint history review: not performed as the device lot details were not provided.Conclusions: it was reported post-operatively about wear through and destruction of the acetabulum, periacetabular osteolysis and abductor destruction.Reported and confirmed via clinician review.The exact cause of the event could not be determined because insufficient information was provided.Further information such as device lot details and return of the device are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient came to (b)(6) clinic complaining of progressive hip pain.An x-ray revealed a disassociated femoral head due to excessive trunnion wear of the femoral stem.During surgery was noted the trunnion had worn to the point that the femoral head had come off.After explanting the accolade tmzf stem a restoration modular stem was used as the replacement device.*update on 04-aug-2021 per medical review: post-operatively it was stated that there was catastrophic failure of the hip, trunnion failure at the taper, metal disease, femoral osteolysis with a well fixed stem, wear through and destruction of the acetabulum, periacetabular osteolysis and abductor destruction.

• Brand Name: TRIDENT PSL WITH PUREFIX HA 54MM
• 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: 12367774
• Report Number: 0002249697-2021-01462
• Device Sequence Number: 3887570
• Product Code: LPH
• UDI-Device Identifier: 07613327037203
• UDI-Public: 07613327037203
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K983382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2021

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 Model Number: 542-11-54F
• Device Catalogue Number: 542-11-54F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/25/2021
• 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: 73 YR
• Patient Weight: 94