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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A MODLUAR HEAD COMPONENT; PROSTHESIS, HIP

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ZIMMER BIOMET, INC. M2A MODLUAR HEAD COMPONENT; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Detachment of Device or Device Component (2907)
Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)
Event Date 03/25/2022
Event Type  Injury  
Event Description
It was reported that approximately eighteen years post-implantation, the patient was revised due to disassociation of the head and stem, trunnion fracture, and significant metal related pathology.All components were revised with extension cabling and claw plating system used to secure femur and reduce eto/bone fragments and proximal femur fracture.Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
(b)(4).The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
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Brand Name
M2A MODLUAR HEAD COMPONENT
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key19114792
MDR Text Key340239565
Report Number0001825034-2024-01028
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062997
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/16/2024
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 Expiration Date04/30/2016
Device Model NumberN/A
Device Catalogue Number11-173664
Device Lot Number368870
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/28/2024
Initial Date FDA Received04/16/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/01/2006
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) Required Intervention; Hospitalization;
Patient SexMale
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