MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALL POLY CONSTRAINED INSERT 46MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Model Number	6260-9-122
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	11/18/2019
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 required revision of her constrained all poly cup, as the bipolar section of the prosthesis dislocated out of the poly outer section.This occurred apparently as the patient rose from sitting to standing from a couch.The outer part of the constrained cup was reamed out of the acetabulum, therefore destroyed during removal.The original surgery was revision of a failed femoral nail.
Event or Problem Description
Patient required revision of her constrained all poly cup, as the bipolar section of the prosthesis dislocated out of the poly outer section.This occurred apparently as the patient rose from sitting to standing from a couch.The outer part of the constrained cup was reamed out of the acetabulum, therefore destroyed during removal.The original surgery was revision of a failed femoral nail.
Additional Manufacturer Narrative
An event regarding disassociation involving a trident liner was reported.The event was confirmed via medical review.Method & results.-product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated that "provided x-ray confirms dislocation/disassociation, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.".Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from 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 stated that "provided x-ray confirms dislocation/disassociation, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.".The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: ALL POLY CONSTRAINED INSERT 46MM
• 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: 9476947
• Report Number: 0002249697-2019-04031
• Device Sequence Number: 353394
• Product Code: KWZ
• UDI-Device Identifier: 07613327013016
• UDI-Public: 07613327013016
• 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: 2019
• 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): 02/20/2020

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: 06/30/2024
• Device Model Number: 6260-9-122
• Device Catalogue Number: 69-2246
• Device Lot Number: V31PMH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 02/20/2020
• 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 Weight: 92