MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 26X42MM; HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS

Catalog Number	UH1-42-26
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.
Event or Problem Description
Revision of patients left hip.The patient had dislocated two times in the past.The patient was revised due to a third dislocation with a dissociation of the bipolar from the femoral head.
Additional Manufacturer Narrative
An event regarding dislocation with disassociation between the uhr bipolar and the femoral head involving a uhr head was reported.The event was not confirmed.-device evaluation and results: visual, dimensional, and functional inspection were not performed as the item was not returned.-medical records received and evaluation: not performed as medical records were not provided.-device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for this lot.The event could not be confirmed nor the root cause of the reported event determined due to the minimal information received for evaluation.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
Event or Problem Description
Revision of patients left hip.The patient had dislocated two times in the past.The patient was revised due to a third dislocation with a dissociation of the bipolar from the femoral head.

• Brand Name: UHR BIPOLAR 26X42MM
• Common Device Name: HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6323880
• Report Number: 0002249697-2017-00537
• Device Sequence Number: 1226349
• Product Code: KWL
• UDI-Device Identifier: 07613327016826
• UDI-Public: (01)07613327016826(11)160126(17)210131(10)DT09TR
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K800207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 04/25/2017

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: 01/31/2021
• Device Catalogue Number: UH1-42-26
• Device Lot Number: DT09TR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2017
• Supplement Report FDA Received Date: 04/25/2017
• 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: 65 YR