MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG CONSTRAINED INSERT 22E; HIP JOINT METAL/POLYMER CONSTRAINED CEMENTED OR UNCEMENTED PROSTHESIS.

Catalog Number 690-00-22E

Device Problem Naturally Worn (2988)

Patient Problem Injury (2348)

Event Date 12/11/2018

Event Type  Injury  

Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

It was reported that the patient's hip was revised due to the femoral head wearing through the outer poly of the constrained liner.

Event Description

It was reported that the patient's hip was revised due to the femoral head wearing through the outer poly of the constrained liner.

Manufacturer Narrative

An event regarding wear involving a trident liner was reported.The event was confirmed through visual inspection.Method & results: device evaluation and results: visual inspection: the reported device was not returned however a photograph was provided for review.The photograph shows a recently explanted trident liner and head with biological matter present.From the photograph provided there is evidence of wear as the head can be seen through the liner.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including lot number, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: TRIDENT 0 DEG CONSTRAINED INSERT 22E
• Type of Device: HIP JOINT METAL/POLYMER CONSTRAINED CEMENTED OR UNCEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8228359
• MDR Text Key: 132426412
• Report Number: 0002249697-2019-00100
• Device Sequence Number: 1
• Product Code: KWZ
• UDI-Device Identifier: 07613327025545
• UDI-Public: 07613327025545
• 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,other
• Type of Report: Initial,Followup
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 690-00-22E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR