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	05/17/2019
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
Surgeon reported that the patient has undergone an urgent revision right total hip replacement due to dislocation of constrained liner.Acetabulum: 44mm stryker trident constrained liner was still engaged with the head and therefore disengaged with the removal key.Stryker rep reported that the bipolar head can be returned, the outer bearing had to be reamed and therefore not available for return.Femur: charnley stem moved and cement mental retained.Surgeon inspected the stem and declared no evidence of wear or impingement.Dislocation occurred on 13th may and surgeon explained that patient was sat washing his foot with the right leg in a figure of 4 position.

• 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: 8695412
• Report Number: 0002249697-2019-02241
• Device Sequence Number: 2005525
• Product Code: KWZ
• UDI-Device Identifier: 07613327025446
• UDI-Public: 07613327025446
• 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: 1998
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/13/2019

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: 08/30/2023
• Device Catalogue Number: 69-2244
• Device Lot Number: PY3Y35
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 06/13/2019
• 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: 87 YR