UNKNOWN CUP N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for UNKNOWN CUP N/A manufactured by Zimmer Biomet, Inc..

Event Text Entries

[185902428] (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.
Patient Sequence No: 1, Text Type: N, H10


[185902429] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001825034-2020-01419
MDR Report Key9908670
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2020-03-10
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DR.
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1ZIMMER BIOMET, INC.
Manufacturer Street56 E. BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN CUP
Generic NamePROSTHESIS, HIP
Product CodeJDI
Date Received2020-03-31
Model NumberN/A
Catalog NumberUNKNOWN CUP
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER BIOMET, INC.
Manufacturer Address56 E. BELL DRIVE WARSAW IN 46582 US 46582


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-31

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