MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 28X45MM; HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS.

Catalog Number	UH1-45-28
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2017
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
A hemiarthroplasty was returned to the operating room when post op x-rays showed the hip had dislocated.Surgeon downsized the bipolar head from a 45 mm to a 44 mm and reduced the hip.
Additional Manufacturer Narrative
An event regarding user error involving an uhr bipolar was reported.The event was not confirmed.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.The event could not be confirmed nor could the root cause be determined because the insufficient medical information was provided.Further information such as return of device, patient history, histopathology report and follow-up notes are needed to investigate this event further.Moreover, as per the communication received, this is not a product issue.Its just a physician¿s complaint for operability.If additional information and/or device becomes available, this investigation will be reopened.
Event or Problem Description
A hemiarthroplasty was returned to the or when post op x-rays showed the hip had dislocated.Surgeon downsized the bipolar head from a 45mm to a 44mm and reduced the hip.

• Brand Name: UHR BIPOLAR 28X45MM
• 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: 6362584
• Report Number: 0002249697-2017-00679
• Device Sequence Number: 474305
• Product Code: KWL
• UDI-Device Identifier: 07613327016918
• UDI-Public: (01)07613327016918(11)160328(17)210331(10)2V6MAT
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K800207
• 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): 04/26/2017

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: 03/31/2021
• Device Catalogue Number: UH1-45-28
• Device Lot Number: 2V6MAT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/30/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2017
• Supplement Report FDA Received Date: 04/26/2017
• 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: 83 YR