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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN EXTREMITY PROSTHESIS, EXTEMITY

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ZIMMER BIOMET, INC. UNKNOWN EXTREMITY PROSTHESIS, EXTEMITY Back to Search Results
Model Number N/A
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Rupture (2208)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation. Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) 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. 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. M. (2015). Semiconstrained total elbow arthroplasty for rheumatoid arthritis patients. Arch orthop trauma surg, doi10. 1007(s00402).
 
Event Description
Information was received based on review of a journal article titled, "semiconstrained total elbow arthroplasty for rheumatoid arthritis patients: one (1) elbow was identified in the article that underwent revision for triceps tendon rupture 8 weeks postoperatively managed by surgical reattachment. There has been no further information provided and the patient outcome is unknown. All other events will be reported in individual records which will be linked to parent record.
 
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Brand NameUNKNOWN EXTREMITY
Type of DevicePROSTHESIS, EXTEMITY
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 Key6996001
MDR Text Key90869856
Report Number0001825034-2017-09850
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 11/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN EXTREMITY
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 Received03/12/2015
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: 11/02/2017 Patient Sequence Number: 1
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