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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK ULNA COMPONENT PROSTHESIS, EXTREMITIES

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ZIMMER BIOMET, INC. UNK ULNA COMPONENT PROSTHESIS, EXTREMITIES Back to Search Results
Catalog Number EXT-C/M ELBOW-ULNA-UNK
Device Problem Loss of Osseointegration (2408)
Patient Problem Inadequate Osseointegration (2646)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Report source: foreign - event occurred in (b)(6). Literature title - outcomes of semiconstrained total elbow arthroplasty performed for arthritis in patients under 55 years old. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-01946. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
Approximately three (3) weeks ago, a journal article was retrieved from journal of shoulder and elbow surgery (2019) that reported a retrospective, single-center study from france from 1998 to 2008 that looked at outcomes of semiconstrained total elbow arthroplasty (tea) for patients with arthritis under 55 years old. The purpose of the study was to investigate the mid-term survivorship of primary tea in patients who underwent a linked semiconstrained arthroplasty before 55 years of age. The study reported one patient underwent a left bipolar elbow revision due to aseptic loosening 5. 5 years post-operatively.
 
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Brand NameUNK ULNA COMPONENT
Type of DevicePROSTHESIS, EXTREMITIES
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key10111134
MDR Text Key194620264
Report Number0001822565-2020-01945
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEXT-C/M ELBOW-ULNA-UNK
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/10/2020
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
Removal/Correction NumberNI

Patient Treatment Data
Date Received: 06/02/2020 Patient Sequence Number: 1
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