MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALL POLY CONSTRAINED INSERT 48MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	69-2248
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Injury (2348)
Date of Event	03/04/2019
Type of Reportable Event	Serious Injury
Additional 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.Device not returned.
Event or Problem Description
Customer reported that the patient underwent revision of a trident all poly cup due to dislocation of the uhr head from within the cup.Patient had a fall prior to the dislocation.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation (reported as dislocation) involving an all poly constrained liner was reported.The event was confirmed based on the x-ray provided.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: the provided medical records were rejected for review by a clinical consultant, who indicated: provided x-ray confirms disassociation and dislocation.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components.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 provided medical records were reviewed by the clinician who indicated that "provided x-ray confirms disassociation and dislocation".The reported dislocation of the hip joint has occurred as a result of disassociation of the inner bearing from the trident all poly constrained cup which is a pre-assembled device sold as a single unit.While the event can be confirmed, the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, office/clinical reports, serial x-rays, lot details and examination of the explanted components are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.It is noted that it was reported that the patient sustained a fall prior to the event.
Event or Problem Description
Customer reported that the patient underwent revision of a trident all poly cup due to dislocation of the uhr head from within the cup.Patient had a fall prior to the dislocation.

• Brand Name: ALL POLY CONSTRAINED INSERT 48MM
• 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: 8470313
• Report Number: 0002249697-2019-01490
• Device Sequence Number: 1761402
• Product Code: KWZ
• UDI-Device Identifier: 07613327025460
• UDI-Public: 07613327025460
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 05/20/2019

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 Catalogue Number: 69-2248
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 05/20/2019
• 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