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	01/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Bipolar disassociated from omnifit eon stem and 28/+5 cocr head during a post op dislocation/reduction.The bipolar and 28/+5 cocr heads were explanted during revision surgery."the cocr head did not come off stem, it was removed in tact with stem.The stem was not revised"."the cocr lfit head was impacted off the stem, stem was not revised".
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.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving a uhr head was reported.The event was confirmed via clinician review.Method & results: -product evaluation and results: the bipolar head and metal head were returned for evaluation.Damage is consistent with attempted assembly/implantation.There was nothing remarkable to notice.Dimensional & functional inspections: not performed as the device was returned damaged.Damage is consistent with attempted assembly/implantation.Due to damage sustained from the assembly/ implantation attempts, any results received from a dimensional/functional inspection would not be reflective of the manufactured state of the device.-clinician review: a review of the provided medical information by a clinical consultant indicated: the x-ray provided demonstrates the dissociation of the bipolar head from the femoral head of the cemented stem confirming this event.The limited information provided precludes the assignment of a root cause for this event.-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 dislocation between femoral head and bipolar head.The event was confirmed via clinician review.The exact cause of the event could not be determined.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 disassociated from omnifit eon stem and 28/+5 cocr head during a post op dislocation/reduction.The bipolar and 28/+5 cocr heads were explanted during revision surgery."the cocr head did not come off stem, it was removed in tact with stem.The stem was not revised"."the cocr lfit head was impacted off the stem, stem was not revised".

• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13423144
• Report Number: 0002249697-2022-00166
• Device Sequence Number: 5328029
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2022

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: UH1-51-28
• Device Catalogue Number: UH1-51-28
• Device Lot Number: RT8P80
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 05/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2021
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown