MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 28X51MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number	UH1-51-28
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/23/2024
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.
Event or Problem Description
Postoperative dislocation of implants.
Event or Problem Description
Postoperative dislocation of implants.
Additional Manufacturer Narrative
An event regarding dislocation involving a uhr head was reported.The event was confirmed via medical review.Method & results: -product evaluation and results: visual inspection of the returned devices indicated that the devices were returned in assembled form and that the polyethylene portion of the device has minor deformation/nicks.Damage is consistent with explantation.-clinician review: a review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had a hybrid right bipolar hip arthroplasty since i was able to see an x-ray with the implant in place.I can also confirm that the patient sustained a dislocation and then disassociation since i was able to see sequential x-rays.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of dislocation and disassociation of a bipolar component one day following surgery are multifactorial.In this case i believe there may have been a mismatch between the size of the acetabulum and the chosen size of the bipolar implant.In addition the acetabulum appears abnormal, dysplastic and might well have a deficient superior and posterior wall.These conditions might well contribute to dislocation.The disassociation occurs when an attempt at closed reduction leverages the bipolar component on the bony structures and therefore it disassociates.In my opinion this is an iatrogenic complication and i would not assign any causality to the implant itself." -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to dislocation.A review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient had a hybrid right bipolar hip arthroplasty since i was able to see an x-ray with the implant in place.I can also confirm that the patient sustained a dislocation and then disassociation since i was able to see sequential x-rays.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of dislocation and disassociation of a bipolar component one day following surgery are multifactorial.In this case i believe there may have been a mismatch between the size of the acetabulum and the chosen size of the bipolar implant.In addition, the acetabulum appears abnormal, dysplastic and might well have a deficient superior and posterior wall.These conditions might well contribute to dislocation.The disassociation occurs when an attempt at closed reduction leverages the bipolar component on the bony structures and therefore it disassociates.In my opinion this is an iatrogenic complication and i would not assign any causality to the implant itself." visual inspection of the returned devices indicated that the devices were returned in assembled form and that the polyethylene portion of the device has minor deformation/nicks.Damage is consistent with explantation.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: UHR BIPOLAR 28X51MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21190146
• Report Number: 0002249697-2025-00091
• Device Sequence Number: 3441839
• Product Code: KWL
• UDI-Device Identifier: 07613327017137
• UDI-Public: 07613327017137
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K800207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

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 Catalogue Number: UH1-51-28
• Device Lot Number: W08A96
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/24/2024
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 39 KG