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	Fall (1848)
Date of Event	04/13/2022
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.
Event or Problem Description
Dislocation due to patient fall.It could not be reduced at another hospital.During reduction the bipolar cup and head came off.The bipolar cup and head were replaced.
Event or Problem Description
Dislocation due to patient fall.It could not be reduced at another hospital.During reduction the bipolar cup and head came off.The bipolar cup and head were replaced.
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 inspection 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.Material analysis: material analysis was not performed as the event does not relate to material integrity.-clinician review: no medical records were received for review with a clinical consultant.-product history review: could not be performed as lot code information was unknown.  -complaint history review: could not be performed as lot code information was unknown.  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 inspection 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.Material analysis: material analysis was not performed as the event does not relate to material integrity.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.

• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14335816
• Report Number: 0002249697-2022-00657
• Device Sequence Number: 17452252
• Product Code: KWL
• UDI-Device Identifier: 07613327016956
• UDI-Public: 07613327016956
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K800207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2022

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: UH1-46-28
• Device Catalogue Number: UH1-46-28
• Device Lot Number: UNKNOWN
• 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: 04/14/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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