MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG CONSTRAINED INSERT 28F; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	690-00-28F
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Shell has already been reported for malposition under mfr# 0002249697-2018-03922.Same shell remains implanted.For this pi, only reporting constrained liner, as shell was previously reported.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 right hip was revised due to disassociation of the constrained liner from the acetabular shell.Rep provided pre-revision x-rays, pictures of the explants, and an implant sheet and reported that no further information will be provided by the hospital or surgeon.This pi is for revision 2.
Additional Manufacturer Narrative
An event regarding disassociation of a trident constrained liner from the shell component was reported.The event was confirmed based on medical review.Method & results: -device evaluation and results: not performed as product was not returned.-clinician review: a review of the provided medical records by a clinical consultant concluded: cup malposition in absent anteversion, not addressed during previous revision procedures 6-months and 2-years earlier, in combination with the use of a constrained liner with it¿s inherent reduced range of motion has contributed to impingement with a repetitive overload condition on the liner locking mechanism causing ultimately an intraprosthetic dislocation in the constrained liner requiring a third revision surgery.-device history review: all 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 reported lot.Conclusion: a review of the provided medical records by a clinical consultant concluded: cup malposition in absent anteversion, not addressed during previous revision procedures 6-months and 2-years earlier, in combination with the use of a constrained liner with it¿s inherent reduced range of motion has contributed to impingement with a repetitive overload condition on the liner locking mechanism causing ultimately an intraprosthetic dislocation in the constrained liner requiring a third revision surgery.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's right hip was revised due to disassociation of the constrained liner from the acetabular shell.Rep provided pre-revision x-rays, pictures of the explants, and an implant sheet and reported that no further information will be provided by the hospital or surgeon.This pi is for revision 2.

• Brand Name: TRIDENT 0 DEG CONSTRAINED INSERT 28F
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8738100
• Report Number: 0002249697-2019-02397
• Device Sequence Number: 2296559
• Product Code: KWZ
• UDI-Device Identifier: 07613327025552
• UDI-Public: 07613327025552
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2019

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: 06/30/2023
• Device Catalogue Number: 690-00-28F
• Device Lot Number: PK74J4
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 08/14/2019
• 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