MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALL POLY CONSTRAINED INSERT 44MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	69-2244
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/28/2019
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
It was reported that the patient's left hip was revised.As reported by rep: "patient dislocated, disassociating the [competitor] inner bipolar component from the constrained liner".A stryker 44mm all poly constrained liner was swapped for another 44mm all poly constrained liner.Rep reported that no further information will be released by the hospital or surgeon.
Event or Problem Description
It was reported that the patient's left hip was revised.As reported by rep: "patient dislocated, disassociating the [competitor] inner bipolar component from the constrained liner".A stryker 44mm all poly constrained liner was swapped for another 44mm all poly constrained liner.Rep reported that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
An event regarding disassociation as a result of use outside of indication of a trident liner was reported.Conclusion: based on the provided information it has been determined that this event is associated with an off-label application.The ifu qin 4357 ver d which was packaged with the device states 'do not substitute another manufacturer¿s device for any component of the howmedica osteonics total hip system.The trident constrained acetabular insert orthopaedics surgical protocol, literature number: lsp44 rev.3 ms/gs 03/12 was reviewed and states 'the trident® constrained acetabular insert is designed specifically for the stryker uhr® bipolar head.' no further investigation is required at this time.

• Brand Name: ALL POLY CONSTRAINED INSERT 44MM
• 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: 8552067
• Report Number: 0002249697-2019-01714
• Device Sequence Number: 2443880
• Product Code: KWZ
• UDI-Device Identifier: 07613327025446
• UDI-Public: 07613327025446
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 06/03/2019

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: 08/31/2021
• Device Catalogue Number: 69-2244
• Device Lot Number: PE27XM
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 06/03/2019
• 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 Age: 70 YR