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

Model Number	690-00-28G
Medical Device Problem Codes	Material Separation (1562); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	12/11/2019
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.Device not returned.
Event or Problem Description
Patient dislocation of right hip replacement.Disassociation of trident constrained liner apparent on x-ray.
Additional Manufacturer Narrative
An event regarding disassociation involving a trident liner was reported.The event was confirmed by visual analysis of the device.Method & results: device evaluation and results:the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted trident constrained liner.It is evident from the photos that the device was disassociated both internally and externally post explantation.The liner has been explanted in two pieces, one piece with the head still implanted and one piece of the liner showing evidence of explantation damage.Material analysis, visual, functional and dimensional inspections 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: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, xrays 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 reopened.
Event or Problem Description
Patient dislocation of right hip replacement.Disassociation of trident constrained liner apparent on x-ray.

• 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: 9568176
• Report Number: 0002249697-2020-00059
• Device Sequence Number: 13548648
• Product Code: KWZ
• UDI-Device Identifier: 07613327025583
• UDI-Public: 07613327025583
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 03/04/2020

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: 07/31/2022
• Device Model Number: 690-00-28G
• Device Catalogue Number: 690-00-28G
• Device Lot Number: 2019KV
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 03/04/2020
• 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: 87 YR
• Patient Weight: 78