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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING SWITZERLAND GMBH ZNN, CMN FEMORAL NAIL, CCD 125, RIGHT, 10 MM, 21.5 CM TRAUMA PROTHESIS

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ZIMMER MANUFACTURING SWITZERLAND GMBH ZNN, CMN FEMORAL NAIL, CCD 125, RIGHT, 10 MM, 21.5 CM TRAUMA PROTHESIS Back to Search Results
Model Number N/A
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Non-union Bone Fracture (2369)
Event Date 06/16/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4). Medical devices: znn, cmn lag screw, 10. 5 mm, 115 mm including set screw , item # 47248511510 , lot # 2941276 5. 0 mm diameter cortical screw - red fixed angle 3. 5 mm hex head , item # 47248403550 , lot # 64079925 set screw, 8 mm, 21 mm, hex 3. 5 mm , item# 47249300000 , lot# 1643922n. Multiple mdr reports were filed for this event, please see associated reports: (b)(4). The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
 
Event Description
It was reported that the fracture on the right hip failed to heal. About 1,5 months after the implantation, the patient underwent revision surgery. Due diligence is in progress for this complaint; to date no additional information or product has been received.
 
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Brand NameZNN, CMN FEMORAL NAIL, CCD 125, RIGHT, 10 MM, 21.5 CM
Type of DeviceTRAUMA PROTHESIS
Manufacturer (Section D)
ZIMMER MANUFACTURING SWITZERLAND GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER MANUFACTURING SWITZERLAND 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 Key14998943
MDR Text Key295769448
Report Number0009613350-2022-00361
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47-2493-210-10
Device Lot Number3076204
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/25/2021
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: 07/13/2022 Patient Sequence Number: 1
Treatment
SEE H10 NARRATIVE
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