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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INTERCHANGEABLE HUMERAL ASSEMBLY FOR CEMENTED USE PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. INTERCHANGEABLE HUMERAL ASSEMBLY FOR CEMENTED USE PROSTHESIS, ELBOW Back to Search Results
Catalog Number 32810502704
Device Problems Unstable (1667); Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692); Joint Laxity (4526)
Event Date 11/09/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: 32810504302 interchangeable ulnar assembly plasma sprayed extra small right 3 inch length 64363467. Foreign report source: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown. 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 - 2020 - 03910.
 
Event Description
It was reported that the initial right total elbow arthroplasty was performed. Subsequently, the patient was revised due to separation of the joint axis pin. No additional patient consequences were reported.
 
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Brand NameINTERCHANGEABLE HUMERAL ASSEMBLY FOR CEMENTED USE
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 Key10886368
MDR Text Key217927845
Report Number0001822565-2020-03909
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K181307
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number32810502704
Device Lot Number64363410
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient Treatment Data
Date Received: 11/23/2020 Patient Sequence Number: 1
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