FDA.reportPublic FDA data

MAUDE MDR 6624

MDR report key
6624
Report number
33446-1993-00029
Event key
0
Event type
3
Date of event
1993-07-23
Date received
1993-09-20
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 KNEETOTAL KNEEHOWMEDICA, INC.EEA6638-5-607, 6638-3-960OHCYBA, OHCYRAYN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11993-09-2001. R

Event Narratives#

D

Patient 1

BASEPLATE METAL BROKEN. NEW INSERT AND BASEPLATE IMPLANTED. ALSO REPLACED WORN PATELLA.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT 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.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.