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

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problem Injury (2348)

Event Date 11/07/2018

Event Type  Injury  

Manufacturer Narrative

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.A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.Product not returned.

Event Description

It was reported that patient's right hip was revised after patient complained of clicking.Intra-operatively, the locking mechanism between the constrained liner and the shell failed, and the liner disassociated from the shell.Liner and c-taper lfit femoral head were revised to similar stryker devices.

Manufacturer Narrative

An event regarding disassociation involving a trident liner was reported.Clinician review of the provided medical notes revealed cup malposition in absent anteversion 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 revision surgery.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: cup malposition in absent anteversion 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 revision surgery.Product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical records by a clinical consultant indicated: cup malposition in absent anteversion 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 revision surgery.The exact cause of the event could not be determined because insufficient information was provided.Further information such as device identification and return, additional pre and post operative x-rays, operative reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause.

Event Description

It was reported that patient's right hip was revised after patient complained of clicking.Intra-operatively, the locking mechanism between the constrained liner and the shell failed, and the liner disassociated from the shell.Liner and c-taper lfit femoral head were revised to similar stryker devices.

• Brand Name: TRIDENT 0 DEG CONSTRAINED INSERT 28F
• Type of Device: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8135285
• MDR Text Key: 129434685
• Report Number: 0002249697-2018-03920
• Device Sequence Number: 1
• Product Code: KWZ
• UDI-Device Identifier: 07613327025552
• UDI-Public: 07613327025552
• Combination Product (y/n): N
• PMA/PMN Number: K061654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 690-00-28F
• Device Lot Number: WL2R9E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 67 YR