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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 28X50MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
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STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 28X50MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL Back to Search Results
Model Number UH1-50-28
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Discomfort (2330)
Date of Event 07/28/2021
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 relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event or Problem Description
Bipolar head disassociated from stem and femoral head construct during a water skiing fall.Update: the patient was revised on (b)(6) 2021.
 
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Brand Name
UHR BIPOLAR 28X50MM
Common Device Name
PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key12344945
Report Number0002249697-2021-01429
Device Sequence Number4115241
Product Code KWL
UDI-Device Identifier07613327017076
UDI-Public07613327017076
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K800207
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2021
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/19/2021
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 Date03/31/2010
Device Model NumberUH1-50-28
Device Catalogue NumberUH1-50-28
Device Lot Number27351501
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/28/2021
Initial Report FDA Received Date08/19/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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