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

Model Number	UH1-52-28
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	02/22/2022
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.Device not returned to the manufacturer.
Event or Problem Description
Bipolar cup dislocated from inner head.He had two reduction within two weeks.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation 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 consistent with explantation.Dimensional & functional inspection: dimensional and functional inspections could not be performed because the device was returned damaged.Due to damage sustained from the dislocation event & explantation, any results received from a dimensional/functional inspection 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 bipolar (uhr) head.Visual inspection of the returned device indicated that the polyethylene portion of the device has minor deformation/nicks consistent with explantation.Dimensional and functional inspections could not be performed because the device was returned damaged.Due to damage sustained from the dislocation event & explantation, any results received from a dimensional/functional inspection would not be reflective of the manufactured state of the device.Further information such as pre- and post-operative x-rays and the primary & revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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.
Event or Problem Description
Bipolar cup dislocated from inner head.He had two reduction within two weeks.Update: stem was revised for an unknown reason.

• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13786485
• Report Number: 0002249697-2022-00402
• Device Sequence Number: 4022520
• Product Code: KWL
• UDI-Device Identifier: 07613327017182
• UDI-Public: 07613327017182
• 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: 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): 06/24/2022

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: 06/30/2026
• Device Model Number: UH1-52-28
• Device Catalogue Number: UH1-52-28
• Device Lot Number: E64DMJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 03/16/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2021
• 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: Male
• Patient Weight: 49 KG