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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INTERCHANGEABLE ULNAR ASSEMBLY PLASMA SPRAYED EXTRA SMALL LEFT 3 INCH LENGTH PROSTHESIS ELBOW

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ZIMMER BIOMET, INC. INTERCHANGEABLE ULNAR ASSEMBLY PLASMA SPRAYED EXTRA SMALL LEFT 3 INCH LENGTH PROSTHESIS ELBOW Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Naturally Worn (2988)
Patient Problems Pain (1994); Reaction (2414)
Event Date 06/20/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). (udi): n/a. Concomitant medical products: catalog #: 32810502704, interchangeable humeral assembly, lot # 62748297. Catalog #: 32810502701, pin/bushing replacement kit, lot # 61627342. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its 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: 0001822565-2020-01747, 0001822565-2020-01750. Location unknown.
 
Event Description
It was reported that a patient had an initial left total elbow arthroplasty performed approximately 5 years ago. Subsequently, the patient was revised about 2 years ago due to pain. During the revision, significant metallosis and poly wear were noted. The ulnar and humeral poly bushings were replaced without complication. No additional information is available.
 
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Brand NameINTERCHANGEABLE ULNAR ASSEMBLY PLASMA SPRAYED EXTRA SMALL LEFT 3 INCH LENGTH
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 Key10079518
MDR Text Key191728729
Report Number0001822565-2020-01749
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2019
Device Model NumberN/A
Device Catalogue Number32810504301
Device Lot Number62527847
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 Received09/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/13/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 05/21/2020 Patient Sequence Number: 1
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