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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL NAIL YELLOW 9.3MM DIAMETER 34CM LENGTH ROD, FIXATION/TRAUMA

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ZIMMER BIOMET, INC. TIBIAL NAIL YELLOW 9.3MM DIAMETER 34CM LENGTH ROD, FIXATION/TRAUMA Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Failure of Implant (1924)
Event Date 08/31/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: item#: 47-2484-030-50, z nail 5. 0x30 cort screw fa; lot#: 64869036. Item#: 47-2484-030-50, z nail 5. 0x30 cort screw fa; lot#: 64875696. Item#: 47-2484-027-50, z nail 5. 0x27. 5 cort screw fa; lot#: 64283166. Item#: 47-2484-042-50, z nail 5. 0x42. 5 cort screw fa; lot#: 65023623. Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient had an initial right lower leg surgery when the implant was implanted. Subsequently, approximately six (6) weeks later during a follow up appointment, it was noticed on x-ray that the implant was fractured. The patient was revised approximately two (2) weeks later to explant the implant and replace it with a larger implant.
 
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Brand NameTIBIAL NAIL YELLOW 9.3MM DIAMETER 34CM LENGTH
Type of DeviceROD, FIXATION/TRAUMA
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 Key12514948
MDR Text Key272773720
Report Number0001822565-2021-02731
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082770
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47249534009
Device Lot Number64941866
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 Received08/31/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/15/2021
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: 09/22/2021 Patient Sequence Number: 1
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