MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 28X52MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number	UH1-52-28
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding disassociation involving a uhr head was reported.The event was confirmed via review of the provided medical records by a clinical consultant.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: i can confirm that the patient had a cemented bipolar left hip arthroplasty that sustained a disassociation of the bipolar component from the femoral head, which remained on the femoral component since i was able to review an x-ray with those findings.Root cause analysis: the root cause of bipolar head disassociation from the femoral head on the femoral component cannot be determined with absolute certainty, but in this case with reasonable certainty.It appears that the bipolar arthroplasty was functioning reasonably well until it dislocated.It is not uncommon for a bipolar head to become dislodged, following an attempt at reduction into the acetabulum.The root cause of a dislocation of the bipolar head from the acetabulum cannot be determined with certainty.The causes are multifactorial, including surgical technique, patient activity level, lifestyle, and bmi.With the information provided, i would not assign any causality of either event events to the implant itself.-device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusions: it was reported that the patient was revised due to disassociation of the head from the uhr bipolar head.A review of the provided medical records by a clinical consultant indicated: i can confirm that the patient had a cemented bipolar left hip arthroplasty that sustained a disassociation of the bipolar component from the femoral head, which remained on the femoral component since i was able to review an x-ray with those findings.Root cause analysis: the root cause of bipolar head disassociation from the femoral head on the femoral component cannot be determined with absolute certainty, but in this case with reasonable certainty.It appears that the bipolar arthroplasty was functioning reasonably well until it dislocated.It is not uncommon for a bipolar head to become dislodged, following an attempt at reduction into the acetabulum.The root cause of a dislocation of the bipolar head from the acetabulum cannot be determined with certainty.The causes are multifactorial, including surgical technique, patient activity level, lifestyle, and bmi.With the information provided, i would not assign any causality of either event events to the implant itself.The exact cause of the event could not be determined because insufficient information was provided.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's left hemi hip was revised.The patient dislocated and a closed reduction was attempted.The bipolar component then dissociated from the femoral head.A bipolar component and 28 +2.5 c-taper head were revised to another bipolar component (same catalog number) and a 28 +5 c-taper head.Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: UHR BIPOLAR 28X52MM
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22975486
• Report Number: 0002249697-2025-00951
• Device Sequence Number: 9256583
• Product Code: KWL
• UDI-Device Identifier: 07613327017182
• UDI-Public: 07613327017182
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K800207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/05/2025

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: UH1-52-28
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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