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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN INSTRUMENT ELBOW, ARTHROPLASTY

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ZIMMER BIOMET, INC. UNKNOWN INSTRUMENT ELBOW, ARTHROPLASTY Back to Search Results
Model Number N/A
Device Problem Unclear Information (4052)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/23/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Udi # n/a. Report source: foreign country: (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the surgeon could not get the reduction tool instrument in between the ulna and the ulna component to be able to use the tool. Hence, surgeon used tamps. But, due to the use of tamps, poly was damaged and the screws could not seat. Hence, surgeon had to revise the articulation kit.
 
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Brand NameUNKNOWN INSTRUMENT
Type of DeviceELBOW, ARTHROPLASTY
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 Key8350528
MDR Text Key136510699
Report Number0001822565-2019-00774
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
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 Received05/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 02/19/2019 Patient Sequence Number: 1
Treatment
00840009500, ARTICULATION KIT, 63820028
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