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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXEL ULNAR COMPONENT PLASMA SPRAYED SIZE 5 115 MM PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. NEXEL ULNAR COMPONENT PLASMA SPRAYED SIZE 5 115 MM PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cellulitis (1768); Fever (1858); Pain (1994); Swelling (2091); Post Operative Wound Infection (2446)
Event Date 10/30/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: 211225 compr srs ic seg - 60mm 875550, 211238 compr srs mod stem - 12x100mm 653050, 110029938 compr srs 50mm dst hum bdy rt 213040, unknown unknown nexel articulation kit. (b)(6). The complaint is under investigation. 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 - 2018 - 06973.
 
Event Description
It was reported that the patient underwent an initial right distal humeral resection and implantation of a distal humerus and elbow arthroplasty. Subsequently, the patient experienced superficial wound infection two weeks post implantation and underwent an irrigation and debridement procedure for deep wound infection six weeks post implantation. It was reported that the infection was related to procedure but not implants. No additional information was provided.
 
Manufacturer Narrative
The complaint is under investigation. Once the investigation is completed a follow up report will be submitted.
 
Event Description
No additional information is available at this time.
 
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Brand NameNEXEL ULNAR COMPONENT PLASMA SPRAYED SIZE 5 115 MM
Type of DevicePROSTHESIS, ELBOW
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8171957
MDR Text Key130613831
Report Number0001822565-2018-06972
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
PMA/PMN Number
K123862
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 04/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number00840002511
Device Lot Number62952428
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/17/2018 Patient Sequence Number: 1
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