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

Catalog Number	690-00-28G
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
The end user has reported that 2.5 months after the surgery, the constrained insert was separated into 2 pieces.
Additional Manufacturer Narrative
An event regarding disassociation involving a constrained liner was reported.The event was confirmed by inspection of the received image.Method & results: device evaluation and results: the device was not returned.Visual inspection of the received intra op image noted that the constrained liner is disassociated.Dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.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: it was reported that the constrained insert was separated into 2 pieces.Visual inspection of the received intra op image noted that the constrained liner is disassociated.The exact cause of the event could not be determined because insufficient information was provided.Additional information including patient details, 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.Product surveillance will continue to monitor for trends.
Event or Problem Description
The end user has reported that 2.5 months after the surgery, the constrained insert was separated into 2 pieces.

• Brand Name: TRIDENT 0 DEG CONSTRAINED INSERT 28G
• 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: 9139639
• Report Number: 0002249697-2019-03353
• Device Sequence Number: 1825309
• Product Code: KWZ
• UDI-Device Identifier: 07613327025583
• UDI-Public: 07613327025583
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2019

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: 05/31/2022
• Device Catalogue Number: 690-00-28G
• Device Lot Number: JN5V6M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 12/04/2019
• 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 Weight: 95