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

Catalog Number	UH1-48-28
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	01/05/2024
Type of Reportable Event	Serious Injury
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.H3 other text : not returned.
Event or Problem Description
It was reported by sale rep that there is a revision surgery performed due to dislocation, uhr bipolar head was dislocated from inner head after primary surgery performed (b)(6) 2023.Revision date (b)(6) 2024.
Additional Manufacturer Narrative
An event regarding disassociation involving a uhr head was reported.The event was confirmed via medical review.Method & results: -product evaluation and results: 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 records by a clinical consultant indicated: "i can confirm that the patient underwent a primary bipolar cementless hip arthroplasty since i was able to see x-rays with the implant in place albeit dislocated and disassociated.Although i saw an x-ray dated (b)(6) 2023 with the bipolar implant located, i cannot confirm that the patient actually underwent the revision since i have no documentation such as office notes, operation report or any other supporting information.The root cause of this event cannot be determined with certainty.Causes of early postoperative dislocation can be attributed to surgical technique, in restoring the proper leg length and soft tissue tension as well as proper sizing and anteversion, etc.Patient factors can also contribute including the patient's postoperative activities and bmi, as well as the ability to follow postoperative instructions as given by the surgeon.I would not assign any causality to the implant itself." -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.A review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient underwent a primary bipolar cementless hip arthroplasty since i was able to see x-rays with the implant in place albeit dislocated and disassociated.Although i saw an x-ray dated (b)(6) 2023 with the bipolar implant located, i cannot confirm that the patient actually underwent the revision since i have no documentation such as office notes, operation report or any other supporting information.The root cause of this event cannot be determined with certainty.Causes of early postoperative dislocation can be attributed to surgical technique, in restoring the proper leg length and soft tissue tension as well as proper sizing and anteversion, etc.Patient factors can also contribute including the patient's postoperative activities and bmi, as well as the ability to follow postoperative instructions as given by the surgeon.I would not assign any causality to the implant itself." 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.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported by sale rep that there is a revision surgery performed due to dislocation, uhr bipolar head was dislocated from inner head after primary surgery performed (b)(6) 2023.Revision date (b)(6) 2024.

• 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: 18728520
• Report Number: 0002249697-2024-00247
• Device Sequence Number: 20268984
• Product Code: KWL
• UDI-Device Identifier: 07613327017014
• UDI-Public: 07613327017014
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K800207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2024

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 Catalogue Number: UH1-48-28
• Device Lot Number: VA02XM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 02/18/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male