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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN BUSHING KIT PROSTHESIS, EXTREMITIES

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ZIMMER BIOMET, INC. UNKNOWN BUSHING KIT PROSTHESIS, EXTREMITIES Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Unstable (1667); Naturally Worn (2988)
Patient Problem No Code Available (3191)
Event Date 02/24/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical product(s) unknown humeral component; unknown ulnar component; unknown stems (2). Report source: foreign: event occurred in (b)(6). The product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Discarded.
 
Event Description
It was reported that a patient underwent a replacement of bushing kit. Subsequently, the patient underwent a revision procedure to replace the bushing kit due to wear, fracture and instability. No additional patient consequences were reported.
 
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Brand NameUNKNOWN BUSHING KIT
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 Key9777031
MDR Text Key191740141
Report Number0001822565-2020-00749
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
N/A
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 05/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberEXT-C/M ELBOW-UNKNOWN-BEARING
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 Received05/06/2020
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 NumberN/A

Patient Treatment Data
Date Received: 03/02/2020 Patient Sequence Number: 1
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