FDA.reportPublic FDA data

MAUDE MDR 9608265

MDR report key
9608265
Report number
0001825034-2020-00298
Event key
0
Event type
3
Date of event
2019-12-19
Date received
2020-01-20
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
1EPOLY RLC 36MM 10DEG SZ24PROSTHESIS, HIPZIMMER BIOMET, INC.OIYN/AEP-105894842180R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-2001. H; 2. R

Event Narratives#

N

Patient 1

(B)(4). CONCOMITANT MEDICAL PRODUCTS: 650-1057 CER BIOLOXD OPTION HD 36MM 2934973, 650-1066 CER OPT TYPE 1 TPR SLEVE 0MM 2920992, PT-116056 REGEN/RNGLC+ LTD 56MM SZ 24 240160, 010000994 G7 APICAL HOLE PLUG 6102385, 51-108080 TPRLC 133 MP T1 PPS SO 8X101MM 6006745, 103532 TI LOW PROFILE SCREW 6.5X25MM 181420, 106024 RINGLOC+ REPLACEMENT RING SZ24 304650. 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 - 00293 SHELL, 0001825034 - 2020 - 00294 HOLE PLUG, 0001825034 - 2020 - 00295 TAPER, 0001825034 - 2020 - 00296 SCREW, 0001825034 - 2020 - 00297 RING.

D

Patient 1

IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT REVISION AND SUBSEQUENTLY, PATIENT UNDERWENT ANOTHER REVISION A YEAR AND A HALF LATER DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND A CEMENT SPACER IMPLANTED. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.