HUMERAL SCREW KIT 2 HUMERAL SCREWS NI 00840009000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-24 for HUMERAL SCREW KIT 2 HUMERAL SCREWS NI 00840009000 manufactured by Zimmer Biomet, Inc..

Event Text Entries

[176261344] (b)(4). Concomitant medical products: humeral component size 4 cat# 00840004415 lot# 63257171, ulnar component size 4 cat# 00840002407 lot# 64083002, articulation kit size 4 cat# 00840009400 lot# 63991814. The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 00272, 0001822565 - 2020 - 00274, 0001822565 - 2020 - 00275.
Patient Sequence No: 1, Text Type: N, H10


[176261345] It was reported a patient underwent a right total elbow arthroplasty, ulnar decompression and anterior subcutaneous transposition, radial head excision. It was also reported the patient fell approximately 2 weeks later. No abnormal x-ray findings were noted at this visit. The patient had ongoing stiffness and slow progress with range of motion. Approximately 7 months after arthroplasty, a stress reaction in the medial column with minimal displacement was noted on x-ray. The patient was reportedly asymptomatic and implants were in correct placement. No revision has been reported to date. Attempts have been made and additional information on the reported event is unavailable at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001822565-2020-00273
MDR Report Key9627413
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-24
Date of Report2020-01-24
Date of Event2019-07-01
Date Mfgr Received2020-01-08
Device Manufacturer Date2016-05-18
Date Added to Maude2020-01-24
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 NameHUMERAL SCREW KIT 2 HUMERAL SCREWS
Generic NamePROSTHESIS, ELBOW
Product CodeJDC
Date Received2020-01-24
Model NumberNI
Catalog Number00840009000
Lot Number63364033
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. Other 2020-01-24

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