MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 28X51MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number	UH1-51-28
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/22/2021
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
A 51mm bipolar, 28mm +0 c taper cocr head, and 9/132 omnifit hfx pressfit application stem were used in a hemiarthroplasty on (b)(6) 2021.On tuesday (b)(6) 2021 i was contacted by dr, who did the hemi, indicating the patient dislocated, and we would be revising the case.A 51mm bipolar, 28 +5 cocr c taper head, and 7/132 omnifit eon cemented stem was implanted on (b)(6) 2021, all implants from the primary hemi were explanted.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving a uhr head was reported.The event was confirmed.Method & results: -device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the medical records by a clinical consultant indicated "i can confirm that a dislocation of the implant took place since i was able to review xrays that showed the dislocation.I have no explanation why the surgeon found it necessary to remove the femoral implant.Regarding the possible root cause of this event, dislocation in the immediate post-operative period, in the absence of trauma, is almost always surgical technique related.No implant related issues apply in this case." -device 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 reported lot.Conclusion: it was reported that the patient dislocated and a 51mm bipolar, 28mm +0 c taper cocr head, and 9/132 omnifit hfx pressfit application stem was explanted.A review of the medical records by a clinical consultant indicated "i can confirm that a dislocation of the implant took place since i was able to review xrays that showed the dislocation.I have no explanation why the surgeon found it necessary to remove the femoral implant.Regarding the possible root cause of this event, dislocation in the immediate post-operative period, in the absence of trauma, is almost always surgical technique related.No implant related issues apply in this case." 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
51mm bipolar, 28mm +0 c taper cocr head, and 9/132 omnifit hfx pressfit application stem were used in a hemiarthroplasty on 12/11/21.On (b)(6) 2021 i was contacted by dr, who did the hemi, indicating the patient dislocated, and we would be revising the case.A 51mm bipolar, 28 +5 cocr c taper head, and 7/132 omnifit eon cemented stem was implanted on (b)(6) 2021, all implants from the primary hemi were explanted.

• Brand Name: UHR BIPOLAR 28X51MM
• 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: 13259150
• Report Number: 0002249697-2022-00087
• Device Sequence Number: 1580272
• Product Code: KWL
• UDI-Device Identifier: 07613327017137
• UDI-Public: 07613327017137
• 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: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2022

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: 02/28/2026
• Device Model Number: UH1-51-28
• Device Catalogue Number: UH1-51-28
• Device Lot Number: RT1N2N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2021
• 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: Female