MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 28X53MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	UH1-53-28
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's left hip was revised due to dislocation of the uhr bipolar head from the patient's native acetabulum.A hemi hip was converted to a total hip with a constrained liner (stem was retained).Rep confirmed that pictures can be provided and that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
An event regarding dislocation involving a uhr head was reported.The event was confirmed.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 with a clinical consultant indicated "confirmation of event: i can confirm that the patient had a left total hip arthroplasty since i was able to see the implant x-ray.I was also able to see what is described as the device used which was explanted.I was not provided the operation reports so i base my confirmation on the information provided.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of disassociation of a bipolar component from a constrained insert are multifactorial including surgical technique in the way the implant is assembled and inserted.In this case the hip construct dislocated and therefore the disassociation could have occurred due to the trauma of the dislocation of the hip.There was no mention as to whether or not an attempt was made at reduction which could cause disassociation.Patient factors including activity level, and bmi could play a role but i doubt it in this case which happened only a few days after surgery.Implant factors can contribute.The implant must be returned to stryker engineers as described below in order to determine the tolerances.-product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: a review with a clinical consultant indicated "confirmation of event: i can confirm that the patient had a left total hip arthroplasty since i was able to see the implant x-ray.I was also able to see what is described as the device used which was explanted.I was not provided the operation reports so i base my confirmation on the information provided.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of disassociation of a bipolar component from a constrained insert are multifactorial including surgical technique in the way the implant is assembled and inserted.In this case the hip construct dislocated and therefore the disassociation could have occurred due to the trauma of the dislocation of the hip.There was no mention as to whether or not an attempt was made at reduction which could cause disassociation.Patient factors including activity level, and bmi could play a role but i doubt it in this case which happened only a few days after surgery.Implant factors can contribute.The implant must be returned to stryker engineers as described below in order to determine the tolerances.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
No new information.

• Brand Name: UHR BIPOLAR 28X53MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 23743207
• Report Number: 0002249697-2025-01423
• Device Sequence Number: 18248036
• Product Code: JDI
• UDI-Device Identifier: 07613327017205
• UDI-Public: 07613327017205
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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: UH1-53-28
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 04/29/2026
• 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: Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 86 KG