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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, RIGHT, 11X160MM AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL

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ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, RIGHT, 11X160MM AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problems Failure of Implant (1924); Pain (1994)
Event Date 01/12/2022
Event Type  Injury  
Event Description
It was reported that the patient underwent a revision due to migration.
 
Manufacturer Narrative
Customer has indicated that the screw which was revised is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical devices: blunt tip screw, 4x52mm: catalog: 47-2486-052-40; lot: 3024748. Blunt tip screw, 4x46mm: catalog: 47-2486-046-40; lot: 3024720. Blunt tip screw, 4x46mm: catalog: 47-2486-046-40; lot: 3039375. Proximal humerus nail cap, 0mm: catalog: 47-2488-010-00; lot: 3076775. Cortical bone screw, 4x24mm: catalog: 47-2486-124-40; lot: 3068968. Cortical bone screw, 4x26mm: catalog: 47-2486-126-40; lot: 3048178. Cortical bone screw, 4x28mm: catalog: 47-2486-128-40; lot: 3054458. Spider washer: catalog: 47-2488-000-05; lot: 3054287. Zimmer reference: (b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00181.
 
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Brand NamePROXIMAL HUMERUS, RIGHT, 11X160MM
Type of DeviceAFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL
Manufacturer (Section D)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key13889239
MDR Text Key288671362
Report Number0009613350-2022-00182
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K181827
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number47249616011
Device Lot Number3058775
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/13/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/08/2021
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: 03/24/2022 Patient Sequence Number: 1
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