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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS 50MM DST HUM BDY RT PROSTHESIS, SHOULDER

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ZIMMER BIOMET, INC. COMPR SRS 50MM DST HUM BDY RT PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cellulitis (1768); Erythema (1840); Fever (1858); Necrosis (1971); 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; unknown nexel ulnar component; 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: 0001825034 - 2018 - 11344; 0001825034 - 2018 - 11346.
 
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.
 
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Brand NameCOMPR SRS 50MM DST HUM BDY RT
Type of DevicePROSTHESIS, SHOULDER
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 Key8171440
MDR Text Key130609750
Report Number0001825034-2018-11347
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K153398
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/02/2019
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 Number110029938
Device Lot Number213040
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 Received03/28/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/02/2018
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: 12/17/2018 Patient Sequence Number: 1
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