MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 28X46MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number	UH1-46-28
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/18/2022
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
The 46mm bipolar and 28mm inner head disassociated during reduction after the patient dislocated post operatively.Patient was revised.
Event or Problem Description
The 46mm bipolar and 28mm inner head disassociated during reduction after the patient dislocated post operatively.Patient was revised.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and dislocation involving a uhr head was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the polyethylene portion of the device has minor deformation/nicks.Damage is consistent with explantation.Dimensional & functional inspection: dimensional and functional inspections could not be performed because the device was returned damaged.Deformation of uhmwpe can occur due to time spent implanted, dislocation, explantation, and a variety of other factors, and this damage may not be visibly apparent.Any results received from a dimensional inspection of a damaged device would not be reflective of the manufactured state of the device.-clinician review: no medical records were received for review with a clinical consultant.-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 disassociation of the metal head from the uhr bipolar head.Visual inspection of the returned device indicated that the polyethylene portion of the device has minor deformation/nicks.Damage is consistent with explantation.Dimensional and functional inspections could not be performed on the uhr head because the device was returned damaged.Deformation of uhmwpe can occur due to time spent implanted, dislocation, explantation, and a variety of other factors, and this damage may not be visibly apparent.Any results received from a dimensional inspection of a damaged device would not be reflective of the manufactured state of the device.The exact cause of the event could not be determined from the information provided; however, it was reported that the patient was being manipulated to address joint dislocation when the disassociation occurred, and it is likely the forces from this closed reduction may have contributed to the event.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: UHR BIPOLAR 28X46MM
• 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: 13757893
• Report Number: 0002249697-2022-00384
• Device Sequence Number: 5942852
• Product Code: KWL
• UDI-Device Identifier: 07613327016956
• UDI-Public: 07613327016956
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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 Expiration Date: 09/30/2026
• Device Model Number: UH1-46-28
• Device Catalogue Number: UH1-46-28
• Device Lot Number: RD1E05
• 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: 02/18/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2021
• 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 Sex: Unknown