CAPITATE STEM N/A UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2018-12-20 for CAPITATE STEM N/A UNK manufactured by Zimmer Biomet, Inc..

Event Text Entries

[130994327] (b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: part # unk, radial body, lot # unk, part # unk, carpal plate, lot # unk, part # unk, radial stem, lot # unk, part # unk, carpal head, lot # unk, part # unk, radial screw, lot # unk, part # unk, ulnar screw, lot # unk. Event occurred in (b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 11304, 0001825034 - 2018 - 11305, 0001825034 - 2018 - 11306, 0001825034 - 2018 - 11308, 0001825034 - 2018 - 11309, 0001825034 - 2018 - 11310.
Patient Sequence No: 1, Text Type: N, H10


[130994328] It was reported that approximately 8 years post implantation, the patient had reports of swelling and pain to the wrist. During the first-stage revision, the surgeon had discovered loosening, migration and fracturing of the screws, and local metallosis. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001825034-2018-11307
MDR Report Key8184163
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2018-12-20
Date of Report2019-01-04
Date of Event2018-11-27
Date Mfgr Received2019-01-03
Date Added to Maude2018-12-20
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
Event Type3
Type of Report3

Device Details

Brand NameCAPITATE STEM
Generic NamePROSTHESIS, WRIST
Product CodeKWN
Date Received2018-12-20
Model NumberN/A
Catalog NumberUNK
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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 2018-12-20

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