MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 26X47MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number	UH1-47-26
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported through the submission of a revision usage sheet that the patient's right hip was revised.As reported: "patient was dislocated.Removed components and put in smaller stem and shorter neck.Nothing is available per hospital." spoke to rep.The bipolar head dislocated out of the patient's acetabulum.Surgeon reported that the originally implanted stem was too long for the patient's anatomy.The patient's entire hemi hip construct was revised to another hemi hip construct.Rep confirmed there are no allegations against the revised femoral head, and that no further information will be released by the hospital or surgeon.

• Brand Name: UHR BIPOLAR 26X47MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11043063
• Report Number: 0002249697-2020-02712
• Device Sequence Number: 1034352
• Product Code: KWL
• UDI-Device Identifier: 07613327016987
• UDI-Public: 07613327016987
• 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 Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/20/2020

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 Model Number: UH1-47-26
• Device Catalogue Number: UH1-47-26
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 12/20/2020
• 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