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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK NCB PLATE; PLATE, FIXATION, BONE
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ZIMMER BIOMET, INC. UNK NCB PLATE; PLATE, FIXATION, BONE Back to Search Results
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Failure of Implant (1924)
Event Date 10/16/2022
Event Type  Injury  
Event Description
It was reported in a study 5 patients experienced implant loosening.Additional surgery was required; however, no further details have been provided.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
(b)(4).G2: spain.De fortuny, lucas martorell, leal, alexandre coelho, sanchez-soler, juan francisco, martinez-diaz, santos, leon, alfonso, lopez, marques f.(2022) mini-invasive approach vs.Traditional open reduction for periprosthetic hip fracture osteosynthesis with the ncb plate.Injury, vol 54, pgs.706-711.Https://doi.Org/10.1016/j.Injury.2022.10.015.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.
 
Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under 9613350 winter thur.
 
Event Description
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under 9613350 winter thur.
 
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Brand Name
UNK NCB PLATE
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer (Section G)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key18031659
MDR Text Key326871427
Report Number0001822565-2023-02982
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Literature
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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