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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK DISCOVERY ELBOW PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. UNK DISCOVERY ELBOW PROSTHESIS, ELBOW Back to Search Results
Catalog Number UNK DISCOVERY ELBOW
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Reported event was unable to be confirmed as part number and lot number of the device involved in the incident is unknown. Device history record review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation. 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. This report is being submitted late as it has been identified in remediation. Large, r. , tambe, a. , cresswell, t. , espag, m. , & clark, d. I. (2014). Medium-term clinical results of a linked total elbow replacement system. Bone & joint journal, 96-b(10), 1359-1365. Doi:10. 1302/0301-620x. 96b10. 33815.
 
Event Description
Information was received based on review of a journal article titled, "medium-term clinical results of a linked total elbow replacement system". It was reported that one patient underwent a repair and debridement of olecranon bursitis at an unknown date. There has been no further information provided and the patient outcome is unknown.
 
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Brand NameUNK DISCOVERY ELBOW
Type of DevicePROSTHESIS, ELBOW
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 Key7112993
MDR Text Key94728236
Report Number0001825034-2017-11122
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature,study
Reporter Occupation
Type of Report Initial
Report Date 12/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK DISCOVERY ELBOW
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2014
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: 12/13/2017 Patient Sequence Number: 1
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