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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ULNAR COMPONENT PLASMA SPRAYED PROSTHESIS, EXTREMITY

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ZIMMER BIOMET, INC. ULNAR COMPONENT PLASMA SPRAYED PROSTHESIS, EXTREMITY Back to Search Results
Catalog Number 00840002407
Device Problem Insufficient Information (3190)
Patient Problems Fistula (1862); Unspecified Infection (1930)
Event Date 01/28/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Multiple mdr's were filed for this event. Please see associated report(s): 0001822565 - 2019 - 02069, 0001822565 - 2019 - 02070, 0001822565 - 2019 - 02071, 0001822565 - 2019 - 02073. Concomitant medical products: primary di# (b)(4), part 00840004415, lot 62743884, humeral component. Primary di# (b)(4), part 00840009000, lot 63969924, humeral screws. Primary di# (b)(4), part 00840002407, lot 63383785, ulnar component. Primary di# (b)(4), part 00840009400, lot 64013629, articulation kit. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported the patient underwent i&d due to fistulae, a superficial infection was noted less than one year post primary implantation. No further information available at this time.
 
Manufacturer Narrative
Udi# (b)(4) no device was returned for evaluation. Review of provided patient medical records confirms a post operative infection where the patient reportedly picked a scab and it became infected and required antibiotics. The patient also reportedly hit their elblow on a desk. Review of device history records identified no related manufacturing deviations or anomalies that would have contributed to the reported event. Root cause is unknown. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
No further information available at the time of this reporting.
 
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Brand NameULNAR COMPONENT PLASMA SPRAYED
Type of DevicePROSTHESIS, EXTREMITY
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8627771
MDR Text Key145638769
Report Number0001822565-2019-02071
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,health
Type of Report Initial,Followup
Report Date 05/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number00840002407
Device Lot Number63383785
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 05/21/2019 Patient Sequence Number: 1
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