FDA.reportPublic FDA data

MAUDE MDR 9145897

MDR report key
9145897
Report number
0001822565-2019-04278
Event key
0
Event type
3
Date of event
2018-05-30
Date received
2019-10-02
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
12.5 MM FEMALE HEX SCREW 25 MM LENGTHPROSTHESIS, KNEEZIMMER BIOMET, INC.HWDN/A4250990252562154177R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-10-0201. H; 2. R

Event Narratives#

N

Patient 1

(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 42532006702, TIBIA, LOT # 62331211; 42500606002, FEMUR, LOT # 62364751; 00111314001, BONE CEMENT, LOT # 76404338; 00111314001, BONE CEMENT, LOT # 76684363; 00111314001, BONE CEMENT, LOT # 77584367; 00111314001, BONE CEMENT, LOT # 76394338; 42540000032, POLY PATELLA, LOT # 62268836; 42522400512, BEARING, LOT # 62488904. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2018-02910, 3007963827-2018-00092, 0001822565-2018-02914, 0001822565-2018-02913, 0001822565-2018-02912, 0001822565-2019-04277.

D

Patient 1

IT WAS REPORTED THAT APPROXIMATELY 4 YEARS POST IMPLANTATION, THE PATIENT WAS REVISED OF THE RIGHT KNEE DUE TO ASEPTIC LOOSENING AND ARTHROFIBROSIS WITH LIMITED RANGE OF MOTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.