FDA.reportPublic FDA data

MAUDE MDR 9353

MDR report key
9353
Report number
33532-1994-00012
Event key
0
Event type
3
Date of event
1994-09-02
Date received
1994-10-19
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 MODULAR KNEETOTAL KNEEHOWMEDICA, INC.KRN6628-1-809TDTPAY*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11994-10-1901. R

Event Narratives#

D

Patient 1

PT DID FINE AFTER HER TOTAL KNEE UNTIL 8/15/94, WHEN SHE BEGAN TO DISLOCATE MEDIALLY. A 16MM CONSTRAINED INSERT WAS REPLACED IN THE EXISTING BASEPLATE.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. 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. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE 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: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.