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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH UNK NCB PLATE; PLATE, FIXATION, BONE

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ZIMMER GMBH UNK NCB PLATE; PLATE, FIXATION, BONE Back to Search Results
Model Number N/A
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  
Manufacturer Narrative
(b)(4).G2: report source 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 mir will be submitted.
 
Event Description
It was reported in a journal article that 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.
 
Event Description
No additional event information to report at this time.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records could not be performed due to missing lot number.A review of the complaint history could not be performed due to missing reference and lot numbers.Medical records were not provided.With the available information, a definitive root cause could not be determined.No corrective, preventive or field action was taken following the investigation of this event.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.H3 other text : product info is unknown.
 
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Brand Name
UNK NCB PLATE
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ  8404
Manufacturer (Section G)
ZIMMER 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 Key18310868
MDR Text Key330284074
Report Number0009613350-2023-00690
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
N/A
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 01/16/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/13/2023
Initial Date FDA Received12/12/2023
Supplement Dates Manufacturer Received12/29/2023
Supplement Dates FDA Received01/16/2024
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
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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