MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 26X51MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number	UH1-51-26
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.Catalog numbers and lot codes of other devices listed in this report: 6260-9-22626mm +4 lfit v40 head, lot 85219707.6058-0637daccolade c cs 132 nk.Lot r71490 1059-6715 accolade distal spacer, lot dk166y.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.
Event or Problem Description
It was reported the patient's left hip was revised due to suspected infection.An irrigation and debridement with exchange of the femoral and bipolar heads was performed.Rep provided primary and revision usage sheets and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: UHR BIPOLAR 26X51MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 12325498
• Report Number: 0002249697-2021-01398
• Device Sequence Number: 14487266
• Product Code: KWL
• UDI-Device Identifier: 07613327017151
• UDI-Public: 07613327017151
• 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: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2021

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 Date: 12/31/2025
• Device Model Number: UH1-51-26
• Device Catalogue Number: UH1-51-26
• Device Lot Number: AY2YD1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/16/2021
• 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: 67 YR
• Patient Weight: 85