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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 28X51MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL Back to Search Results
Model Number UH1-51-28
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Joint Dislocation (2374)
Event Date 01/11/2022
Event Type  Injury  
Event 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".
 
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.
 
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 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".
 
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Brand Name
UHR BIPOLAR 28X51MM
Type of Device
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 Key13423144
MDR Text Key284869519
Report Number0002249697-2022-00166
Device Sequence Number1
Product Code KWL
UDI-Device Identifier07613327017137
UDI-Public07613327017137
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K800207
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 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
Device Operator Health Professional
Device Model NumberUH1-51-28
Device Catalogue NumberUH1-51-28
Device Lot NumberRT8P80
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/11/2022
Initial Date FDA Received02/02/2022
Supplement Dates Manufacturer Received05/04/2022
Supplement Dates FDA Received05/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/11/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
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