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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN MRS SMALL LONG ULNAR COMPONENT PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN MRS SMALL LONG ULNAR COMPONENT PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED Back to Search Results
Catalog Number UNK_LIM
Device Problem Fracture (1260)
Patient Problem Insufficient Information (4580)
Event Date 06/21/2021
Event Type  Injury  
Manufacturer Narrative
An event regarding crack/fracture involving an unknown mrs implant was reported. The event was confirmed via provided photo and clinician review. Method & results: product evaluation and results: the reported device was not returned however a photograph was provided for review. The photograph shows a recently explanted elbow implant which is fractured. The reported event is confirmed. Medical records received and evaluation: clinician review: a review of the provided medical records by a clinical consultant stated the following comment: confirmation: the event, fracture of an ulnar component, can be confirmed via the x-ray. The off-label use of a left component for the right elbow can be confirmed via the implant stickers (if it was implanted). The revision procedure cannot actually be confirmed without additional medical records. Root cause: the root cause cannot be ascertained without additional medical records and perhaps examination of the explant. Barring a traumatic event, the metal likely fatigued at the fixation point of the ulna. Product history review: not performed as the device lot details were not provided. Complaint history review: not performed as the device lot details were not provided. Conclusions: it was reported that the patient's right elbow was revised due to breakage of the ulnar component. Clinician review of provided records confirmed the event. The exact cause of the event could not be determined because insufficient information was provided. Further information such as device identification details, return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause. No further investigation for this event is possible at this time. If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
It was reported that the patient's right elbow was revised due to breakage of the ulnar component. The broken portion of the ulnar component, bushings and axle were removed. The rest of the component was left in, and a left ulnar component with bushings and axle were intentionally placed into the patient's right radius (rep reported that the surgeon was well aware this was off-label use).
 
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Brand NameUNKNOWN MRS SMALL LONG ULNAR COMPONENT
Type of DevicePROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-LIMERICK
raheen business park
limerick NA
EI NA
Manufacturer Contact
brad curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12171683
MDR Text Key261662748
Report Number0002249697-2021-01207
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial
Report Date 07/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_LIM
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/15/2021 Patient Sequence Number: 1
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