MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 28X47MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number	UH1-47-28
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/20/2025
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
Tha was performed about 2 months ago.Two months after surgery, the patient dislocated hip.The cup was dislodged during manual repositioning.Later, the cup was replaced.The head was also replaced and the neck length was extended.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving a uhr head was reported.The event was confirmed.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 with a clinical consultant indicated "confirmation of event: i can confirm that the patient had a left total hip arthroplasty which subsequently sustained a dislocation and then a disassociation of the acetabular component from the femoral head when an attempt at closed reduction was carried out.I can do so because i was able to see x-rays with the dislocation, disassociation and subsequent replacement of the bipolar component.I cannot confirm the dates since none of the radiographs were dated and i have no operation report reports.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of a postoperative dislocation two months after primary total hip arthroplasty is multifactorial, including surgical technique, especially in the restoration of legs and soft tissue tension in the thigh, patient factors, including following postoperative instructions, lifestyle, activity level, and bmi.I would not assign any causality to the implant itself for dislocation.As to the disassociation of the bipolar component from the femoral head, in my opinion, this is eye genic and occurred because of levering the bipolar component from the femoral head during the attempt at relocation of the hip.Unless stryker engineers determined that there was some mismatch between the outer diameter of the femoral head and the inner diameter of the bipolar component, 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 and disassociation.A review with a clinical consultant indicated "confirmation of event: i can confirm that the patient had a left total hip arthroplasty which subsequently sustained a dislocation and then a disassociation of the acetabular component from the femoral head when an attempt at closed reduction was carried out.I can do so because i was able to see x-rays with the dislocation, disassociation and subsequent replacement of the bipolar component.I cannot confirm the dates since none of the radiographs were dated, and i have no operation report reports.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of a postoperative dislocation two months after primary total hip arthroplasty is multifactorial, including surgical technique, especially in the restoration of legs and soft tissue tension in the thigh, patient factors, including following postoperative instructions, lifestyle, activity level, and bmi.I would not assign any causality to the implant itself for dislocation.As to the disassociation of the bipolar component from the femoral head, in my opinion, this is eye genic and occurred because of levering the bipolar component from the femoral head during the attempt at relocation of the hip.Unless stryker engineers determined that there was some mismatch between the outer diameter of the femoral head and the inner diameter of the bipolar component, i would not assign any causality to the implant itself." 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.
Event or Problem Description
Tha was performed about 2 months ago.Two months after surgery, the patient dislocated hip.The cup was dislodged during manual repositioning.Later, the cup was replaced.The head was also replaced and the neck length was extended.Update: the primary uhr implant was manually repositioned.Stem was not revised.Only revised head and cup.

• Brand Name: UHR BIPOLAR 28X47MM
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21321724
• Report Number: 0002249697-2025-00168
• Device Sequence Number: 8621028
• Product Code: KWL
• UDI-Device Identifier: 07613327016970
• UDI-Public: 07613327016970
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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: UH1-47-28
• Device Lot Number: KT0R0D
• 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: 01/20/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2023
• 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: 85 YR
• Patient Sex: Female
• Patient Weight: 58 KG