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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNK HUMERAL COMPONENT PROSTHESIS, EXTREMITIES Back to Search Results
Catalog Number UNK HUMERAL COMPONENT
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Arthritis (1723); Fall (1848); Bone Fracture(s) (1870); Failure of Implant (1924); Reaction (2414)
Event Date 10/16/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-03872. 2014, exact date is unknown. Unk ulnar component. Foreign - event occurred in (b)(6). 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
It was reported patient underwent an initial elbow procedure approximately six (6) years ago. Subsequently, the patient was revised approximately three (3) years ago due to a periprosthetic fracture and loosening due to falling. Attempts have been made and no further information has been provided.
 
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Brand NameUNK HUMERAL 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 Key10720646
MDR Text Key212780843
Report Number0001825034-2020-03873
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,Followup
Report Date 11/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HUMERAL COMPONENT
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 Received11/17/2020
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 Invalid Data
Removal/Correction NumberNI

Patient Treatment Data
Date Received: 10/22/2020 Patient Sequence Number: 1
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