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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CUSTOM LT IBP MED HUMERAL COMP PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. CUSTOM LT IBP MED HUMERAL COMP PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Cyst(s) (1800)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: 114368 ibp ulna left std intlk 221552. The complaint is under investigation. Once the investigation is completed a follow up report will be submitted.
 
Event Description
It was reported that the patient underwent an initial left elbow arthroplasty and subsequently underwent an unknown procedure due to a blackened triceps cyst approximately nine (9) years post-implantation. No additional information is available at this time.
 
Manufacturer Narrative
The complaint cannot be confirmed as no medical records were provided. Review of the device history record identified no related deviations or anomalies. Root cause could not be determined. If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
No additional information is available to report at this time.
 
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Brand NameCUSTOM LT IBP MED HUMERAL COMP
Type of DevicePROSTHESIS, ELBOW
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8439219
MDR Text Key139414569
Report Number0001825034-2019-01336
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
PMA/PMN Number
CUSTOM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 06/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2012
Device Model NumberN/A
Device Catalogue NumberCP560539
Device Lot Number750420
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 03/21/2019 Patient Sequence Number: 1
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