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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INTERCHANGEABLE ULNAR ASSEMBLY ELBOW PROSTHESIS

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ZIMMER BIOMET, INC. INTERCHANGEABLE ULNAR ASSEMBLY ELBOW PROSTHESIS Back to Search Results
Catalog Number 32810505302
Device Problems Loss of or Failure to Bond (1068); Fracture (1260); Malposition of Device (2616); Insufficient Information (3190)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Udi# (b)(4). Concomitant medical products: 32810502504 interchangeable humeral assembly 61405602, cement, bone surgial simplex p mlro76, restrictor, cement reality 10mm k12315. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 04480.
 
Event Description
It was reported that the patient underwent an initial right elbow arthroplasty. Subsequently, the patient is planned to be revised due to unknown reason. No revision has been reported to date. No additional patient consequences were reported.
 
Event Description
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event. The initial report was forwarded in error and should be voided.
 
Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event. The initial report was forwarded in error and should be voided.
 
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Brand NameINTERCHANGEABLE ULNAR ASSEMBLY
Type of DeviceELBOW PROSTHESIS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9217785
MDR Text Key163182154
Report Number0001822565-2019-04479
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
PMA/PMN Number
K181307
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 01/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2013
Device Catalogue Number32810505302
Device Lot Number61097162
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/17/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/22/2019 Patient Sequence Number: 1
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