MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 28X48MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number	UH1-48-28
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	08/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "total hip arthroplasty revision - left.Diagnosis: unstable hemi-arthroplasty.No further information available per hospital." a bipolar component ad femoral head were revised to a total hip.
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, 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 reported discrepancies.There have been no other events for the lot referenced.
Additional Manufacturer Narrative
An event regarding dislocation involving an uhr head was reported.The event was confirmed via clinician review of the provided medical records.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: this inquiry concerns a patient who underwent a left bipolar hip arthroplasty and at approximately three months after surgery required revision for instability with conversion to a total hip arthroplasty.I can confirm that a dislocation occurred since i was able view an x-ray showing the dislocation.Although i have stickers showing the use of total hip arthroplasty implants, i cannot definitely confirm that it was carried out since i have no operation report or postoperative revision x-ray.The causes of dislocation of a total hip arthroplasty three months after the initial surgery or multifactorial including surgical technique and patient factors.Failure to establish proper soft tissue tension can result in instability.If a posterior approach was used the possibility of disruption of the posterior capsule resulting in positional instability can occur.Also, if a posterior approach is utilized and the patient doesn¿t exercise proper hip precautions, dislocation can occur.I see no causality of the implants themselves.-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.Conclusion: a review of the provided medical records by a clinical consultant indicated: this inquiry concerns a patient who underwent a left bipolar hip arthroplasty and at approximately three months after surgery required revision for instability with conversion to a total hip arthroplasty.I can confirm that a dislocation occurred since i was able view an x-ray showing the dislocation.Although i have stickers showing the use of total hip arthroplasty implants, i cannot definitely confirm that it was carried out since i have no operation report or postoperative revision x-ray.The causes of dislocation of a total hip arthroplasty three months after the initial surgery or multifactorial including surgical technique and patient factors.Failure to establish proper soft tissue tension can result in instability.If a posterior approach was used the possibility of disruption of the posterior capsule resulting in positional instability can occur.Also, if a posterior approach is utilized and the patient doesn¿t exercise proper hip precautions, dislocation can occur.I see no causality of the implants themselves.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
As reported: "total hip arthroplasty revision - left.Diagnosis: unstable hemi-arthroplasty.No further information available per hospital." a bipolar component ad femoral head were revised to a total hip.Patient underwent a left bipolar hip arthroplasty and at approximately three months after surgery required revision for instability with conversion to a total hip arthroplasty.I can confirm that a dislocation occurred since i was able view an x-ray showing the dislocation.

• Brand Name: UHR BIPOLAR 28X48MM
• 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: 15325746
• Report Number: 0002249697-2022-01270
• Device Sequence Number: 6361074
• Product Code: KWL
• UDI-Device Identifier: 07613327017014
• UDI-Public: 07613327017014
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K800207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022

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 Model Number: UH1-48-28
• Device Catalogue Number: UH1-48-28
• Device Lot Number: 7V8MW1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2021
• 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: 83 YR
• Patient Sex: Female
• Patient Weight: 58 KG