FDA.reportPublic FDA data

MAUDE MDR 9746362

MDR report key
9746362
Report number
0001825034-2020-00863
Event key
0
Event type
3
Date of event
2016-03-04
Date received
2020-02-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. CHRISTINA ARNT
Address
56 E. BELL DR. WARSAW IN 46582 US
Phone
574-574-5745
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ECHO POR FMRL NC 12X140MMPROSTHESIS, HIPZIMMER BIOMET, INC.KWZN/A192012267000R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-2401. R

Event Narratives#

N

Patient 1

(B)(4). CONCOMITANT MEDICAL PRODUCTS: US157854 M2A-MAGNUM PF CUP 54ODX48ID 302240; 157448 M2A-MAGNUM MOD HD SZ 48MM 48MM 339660; 139258 M2A-MAGNUM 42-50M TPR 880580. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-00862 INSERT.

D

Patient 1

PATIENT?S LEGAL COUNSEL REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY. THE PATIENT WAS REVISED SEVEN YEARS LATER DUE TO CUP MIGRATION, ALTR, AND CORROSION. DURING THE SURGERY, IT WAS DISCOVERED THAT THE INSERT AND STEM HAD COLD WELDED TOGETHER AND WOULD NOT SEPARATE. WHILE TRYING TO REMOVE THE FEMORAL COMPONENTS, THE FEMUR WAS FRACTURED. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.