MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 26X52MM; HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS.

Model Number	UH1-52-26
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); Joint Dislocation (2374)
Date of Event	04/27/2017
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
Sales rep reported a revision of the left hip.Patient was a recurrent dislocator and was converted from a bipolar to a total hip.
Additional Manufacturer Narrative
An event regarding dislocation involving an uhr head was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection was not performed as the device was not returned.-medical records received and evaluation: no information was received for review with a clinical consultant.-device history review: review of the device history records indicates all devices accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusions: the root cause of this investigation could not be determined as insufficient information was received.Further information such as return of device, x-rays, operative reports, patient history are needed to fully investigate this event.If additional information and/or device become available, this investigation will be reopened.
Event or Problem Description
Sales rep reported a revision of the left hip.Patient was a recurrent dislocator and was converted from a bipolar to a total hip.

• Brand Name: UHR BIPOLAR 26X52MM
• 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: 6591646
• Report Number: 0002249697-2017-01675
• Device Sequence Number: 838590
• Product Code: KWL
• UDI-Device Identifier: 07613327017168
• UDI-Public: (01)07613327017168(11)160714(17)210731(10)LV7H1R
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/27/2017

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: 07/31/2021
• Device Model Number: UH1-52-26
• Device Catalogue Number: UH1-52-26
• Device Lot Number: LV7H1R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2017
• Supplement Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 05/25/2017
• Supplement Report FDA Received Date: 07/27/2017
• 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: 88 YR
• Patient Weight: 76