MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 28X44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	UH1-44-28
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	10/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted 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.
Event or Problem Description
It was reported the patient's right hemi hip was revised.Originally, the bipolar component dislocated from the patient's native acetabulum.A closed reduction was attempted, and the bipolar component dissociated from the femoral head.The bipolar component and head were revised.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation and disassociation involving a uhr head was reported.The event was confirmed via clinician review of the provided medical records.Method & results: product evaluation and results: visual inspection: 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 of the provided medical information by a clinical consultant indicated: "this patient underwent a cementless bipolar hemi arthroplasty and within about four weeks sustained a dislocation.An attempted reduction was carried out but the bipolar component disassociated from the femoral head.I can confirm that the patient underwent a right cementless bipolar hemi arthroplasty since i was able to review the x-rays.I can confirm that the patient sustained a dislocation of the bipolar hemi arthroplasty also since i was able to review the x-rays.I can also confirm that a disassociation occurred since i was able to view the x-ray with the disassociation present.The root cause of early postoperative arthroplasty dislocation are multifactorial as well the causes of femoral/bipolar component disassociation.Factors influencing causality of a postoperative arthroplasty dislocation include surgical technique factors including proper restoration of leg lengths, soft tissue tension and implant positioning, patient factors such as postoperative compliance, activity level and bmi.Factors influencing the causality of postoperative bipolar/femoral head disassociation are also multifactorial including surgical technique factors such as proper assembly and mechanical factors such as dislodging the bipolar component during an attempted reduction of a dislocation of the arthroplasty." 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 bipolar head dislocated out of the patient's native acetabulum and subsequently disassociated from the femoral head.The event was confirmed through clinician review of the provided x-ray images.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.A dimensional inspection was not performed as the reported device was implanted and subsequently explanted.The device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.It was reported that the disassociation event occurred during or following the attempted closed reduction.It is possible that the forces exerted during the closed reduction attempt contributed to the separation of the bipolar component from the femoral head.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
It was reported the patient's right hemi hip was revised.Originally, the bipolar component dislocated from the patient's native acetabulum.A closed reduction was attempted, and the bipolar component dissociated from the femoral head.The bipolar component and head were revised.

• Brand Name: UHR BIPOLAR 28X44MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 15712732
• Report Number: 0002249697-2022-01580
• Device Sequence Number: 4897156
• Product Code: JDI
• UDI-Device Identifier: 07613327016895
• UDI-Public: 07613327016895
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• 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): 01/23/2023

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: UH1-44-28
• Device Catalogue Number: UH1-44-28
• Device Lot Number: AM2VR5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2022
• 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: 87 YR
• Patient Sex: Female