FDA.reportPublic FDA data

MAUDE MDR 9908670

MDR report key
9908670
Report number
0001825034-2020-01419
Event key
0
Event type
3
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
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 CUPPROSTHESIS, HIPZIMMER BIOMET, INC.JDIN/AUNKNOWN CUPUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. H; 2. R

Event Narratives#

N

Patient 1

(B)(4). IMPLANTATION OCCURRED BETWEEN 2015 AND 2017. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN LINER. UNKNOWN STEM. UNKNOWN HEAD . REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-01420, 0001825034-2020-01421, 0001825034-2020-01422. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION SINCE THE DEVICE LOCATION IS UNKNOWN. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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. DEVICE NOT RETURNED FOR EVALUATION.

D

Patient 1

IT WAS REPORTED THAT 19 PATIENTS UNDERWENT AN INITIAL HIP ARTHROPLASTY ON UNKNOWN DATES. SUBSEQUENTLY, THE PATIENTS WERE REVISED DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.