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

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).

• Brand Name: UNKNOWN MRS SMALL LONG ULNAR COMPONENT
• Type of Device: PROSTHESIS, 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 Key: 12171683
• MDR Text Key: 261662748
• Report Number: 0002249697-2021-01207
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• 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 Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_LIM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR