SWANSON WRIST JOINT G488-0203 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-03-02 for SWANSON WRIST JOINT G488-0203 * manufactured by Wright Medical.

Event Text Entries

[20934017] Right wrist implant failure; implant fractured requiring surgery to replace.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number267036
MDR Report Key267036
Date Received2000-03-02
Date of Report2000-01-28
Date of Event2000-01-25
Date Facility Aware2000-01-26
Report Date2000-01-28
Date Reported to Mfgr2000-01-28
Date Added to Maude2000-03-07
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSWANSON WRIST JOINT
Generic NameWRIST JOINT
Product CodeKIG
Date Received2000-03-02
Model NumberG488-0203
Catalog Number*
Lot Number114A009551
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age4 YR
Implant FlagY
Date RemovedV
Device Sequence No1
Device Event Key258507
ManufacturerWRIGHT MEDICAL
Manufacturer Address5677 AIRLINE RD. ARLINGTON TN 38002 US
Baseline Brand NameSWANSON WRIST JOINT IMPLANT
Baseline Generic NameSMALL JOINT COMPONENT
Baseline Model NoNA
Baseline Catalog NoG488-0203
Baseline IDNA
Baseline Device FamilyS J 888.3780
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK850255
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN

Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2000-03-02
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