FDA.reportPublic FDA data

MAUDE MDR 2591

MDR report key
2591
Report number
33934-1993-09007
Event key
0
Event type
3
Date of event
1993-02-01
Date received
1993-03-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
999
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PCA METAL BACK PATELLA BUTTON, 7MM TIBIA INS.KNEE COMPONENTHOWMEDICA, INC.KTXN/AN/AY*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11993-03-0901. R

Event Narratives#

D

Patient 1

THE PLASTIC ON THE TIBIA BROKE. THE PATLLLA WAS FINE, BUT HE REMOVED IT, BECAUSE IT WAS METAL-BACKED. DISPOSED OF BY THE HOSPITALDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.