MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALL POLY CONSTRAINED INSERT 54MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	69-2854
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/04/2017
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 reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
On (b)(6) a stryker cage and cemented all poly constrained were implanted into a patients right hip.On (b)(6) the patient was revised because the inner bipolar had disengaged from the larger part of the constrained.Another constrained was cemented in.
Additional Manufacturer Narrative
Additional information: returned to manufacturer; reason for no evaluation.An event regarding disassociation involving a trident liner was reported.The event was not confirmed.The device showed clear sign of damage likely from the use of an osteotome during explantation.Further review of device with material analysis engineer indicated: damage observed consistent with the explantation process.No medical records or x-rays were made available for evaluation.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies there has been no other event for the lot referenced.The event could not be confirmed nor could the root cause determined as the reported device was returned in used condition with explantation damage and insufficient information was provided.Further information such as pre- and post-op xrays, patient history, histopathology report & follow-up notes are needed to investigate this event further.If additional information becomes available, this investigation will be reopened.
Event or Problem Description
On (b)(6) a stryker cage and cemented all poly constrained were implanted into a patients right hip.On (b)(6) the patient was revised because the inner bipolar had disengaged from the larger part of the constrained.Another constrained was cemented in.

• Brand Name: ALL POLY CONSTRAINED INSERT 54MM
• 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: 6830413
• Report Number: 0002249697-2017-02645
• Device Sequence Number: 661981
• Product Code: KWZ
• UDI-Device Identifier: 07613327025491
• UDI-Public: 07613327025491
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2017

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: 07/26/2021
• Device Catalogue Number: 69-2854
• Device Lot Number: 260JE9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Initial Date Received by Manufacturer: 08/04/2017
• Supplement Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 11/21/2017
• 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: 72 YR