MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT AD ACETABULAR SHELL NO HOLES WITHOUT HA; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	540-01-54F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Osteolysis (2377); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Date of Event	04/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding osteolysis and metallosis involving a trident shell was reported.The event was confirmed via clinician review.Method & results product evaluation and results: the shell and liner were returned in an assembly form.There is cement left on the shell surface.There is nothing else remarkable to report.Clinician review: a review of the provided medical information by a clinical consultant indicated: no clinical or pmh, no examination of explanted components, no laboratory or surgical pathology reports.While the information available for review appears to confirm both event descriptions, insufficient data is present to create a medical report for this patient.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the devices was revised due to a pronounced metallosis.Surgical report also mentioned that osteolysis were noted in the acetabular bed and around the pubic bone as is osteolysis to the dorsocranial and dorsa.Clinician review of provided records indicated that the information available for review appears to confirm the reported event.The shell and liner were returned in an assembly form.There is cement left on the shell surface.There is nothing else remarkable to report.It was also reported massive taper wear of the hip stem; the excessive debris generated from the stem could result in the reported osteolysis and metallosis.However, the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
A complete exchange of the left hip endoprosthesis due to pronounced metallosis and discomfort, was originally reported.Subsequently it was reported that the patient has the same issue in their right hip and revision surgery was planned for (b)(6) 2021.Due to wear, the femoral head dislocated from the taper on (b)(6) 2021 and led to the immobility of the patient.For this reason, a total hip arthroplasty had to be performed on (b)(6) 2021.Replacement of the hip endoprosthesis due to a pronounced metallosis.Update 20-jul-2021: per surgery report (b)(6) 2021 implant revision: using the socket chisel, careful chiseling is performed around the cup which is removed without significant bone loss.Osteolyses are noted in the acetabular bed and around the pubic bone as is osteolysis to the dorsocranial and dorsa.Per evaluation of the returned devices, liner damage was also noted with suspected impingement with the femoral stem.This is for the trident shell (cup).

• Brand Name: TRIDENT AD ACETABULAR SHELL NO HOLES WITHOUT HA
• 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: 12319293
• Report Number: 0002249697-2021-01386
• Device Sequence Number: 19947093
• Product Code: LPH
• UDI-Device Identifier: 04546540080806
• UDI-Public: 04546540080806
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K983502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/13/2021

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: 05/31/2010
• Device Model Number: 540-01-54F
• Device Catalogue Number: 540-01-54F
• Device Lot Number: 13612601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/13/2021
• 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: 68 YR
• Patient Weight: 76