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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE F; PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE F; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problem Bone Fracture(s) (1870)
Event Date 02/16/2022
Event Type  Injury  
Event Description
It was reported that after follow up on a total knee arthroplasty, it was discovered the patient had a tibia bone fracture and the tibial plate was subsiding.The patient was revised approximately two months post implantation; the femur, articular surface, and tibia were replaced.No additional information is available.
 
Manufacturer Narrative
(b)(4).Associated product: femur item 42502806001 lot 64947129.Articular surface item 42512100710 lot 65178106.Foreign - (b)(6).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
No additional information was reported.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
 
Event Description
No additional information reported.
 
Manufacturer Narrative
No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Device history record was reviewed and no discrepancies relevant to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified evidence of a periprosthetic fracture involving the medial tibial plateau extending to involve the medial aspect of the tibial component and the possibility of subsidence of the tibial component.A definitive root cause cannot be determined.Per package insert bone fracture is a known adverse effect of the system.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
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Brand Name
NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE F
Type of Device
PROSTHESIS, KNEE
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 Key13771422
MDR Text Key287612958
Report Number0001822565-2022-00725
Device Sequence Number1
Product Code MBH
UDI-Device Identifier00889024510579
UDI-Public(01)00889024510579(17)310719(10)65016945
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 04/12/2022
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 Health Professional
Device Model NumberN/A
Device Catalogue Number42530007501
Device Lot Number65016945
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/16/2022
Initial Date FDA Received03/15/2022
Supplement Dates Manufacturer Received03/18/2022
04/07/2022
Supplement Dates FDA Received03/24/2022
04/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/26/2021
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 Sequence Number1
Treatment
SEE H10 NARRATIVE.
Patient Outcome(s) Required Intervention; Hospitalization;
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