FDA.reportPublic FDA data

MAUDE MDR 9898280

MDR report key
9898280
Report number
0001822565-2020-01051
Event key
0
Event type
3
Date of event
2018-12-13
Date received
2020-03-30
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
1UNKNOWN LINERPROSTHESIS, HIPZIMMER BIOMET, INC.KWAN/ANINIR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3001. H; 2. R

Event Narratives#

N

Patient 1

(B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #00902602635 ZIMMER HEAD, LOT #66054900, CATALOG #: UNKNOWN, UNKNOWN ACETABULAR SHELL, LOT # UNKNOWN, CATALOG #: UNKNOWN, UNKNOWN ZIMMER HERITAGE STEM, LOT # UNKNOWN. REPORTED EVENT WAS CONFIRMED WITH THE MAUDE REPORT RECEIVED. ECCENTRIC MINIMAL WEAR OF LINER WAS NOTED. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2019 - 00159, 0001822565 - 2019 - 00160.

D

Patient 1

IT WAS REPORTED THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 20 YEARS POST-IMPLANTATION DUE TO CHRONIC TOXIC ENCEPHALOPATHY; PATIENT EXPERIENCED ELEVATED COBALT BLOOD LEVELS, DEVICE CORROSION AND FORMATION OF A PSEUDOTUMOR.