00523201600

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1999-06-02 for 00523201600 manufactured by .

Event Text Entries

[128772] Pt had left total knee replacement in 1986. In 1990 pt fell and required a revision of this total joint. Now she presented with severe medical instability with a valgus deformity on the left. Pt also had severe pain requiring revision surgery to remove and replace. All components were replaced.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1822565-1999-00051
• MDR Report Key: 226059
• Report Source: 06
• Date Received: 1999-06-02
• Date of Event: 1999-04-27
• Date Mfgr Received: 1999-05-11
• Device Manufacturer Date: 1985-07-01
• Date Added to Maude: 1999-06-10
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 0
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Generic Name: TIBIAL RETAINER 7.5X58
• Product Code: GCZ
• Date Received: 1999-06-02
• Model Number: NA
• Catalog Number: 00523201600
• Lot Number: 563812
• ID Number: NA
• Operator: LAY USER/PATIENT
• Device Eval'ed by Mfgr: R
• Implant Flag: Y
• Date Removed: Y
• Device Sequence No: 1
• Device Event Key: 219211
• Baseline Brand Name: ZIMMER
• Baseline Generic Name: TIBIAL RETAINER 7.5X58
• Baseline Model No: NA
• Baseline Catalog No: 00523201600
• Baseline ID: NA
• Baseline Device Family: I/B TOTAL KNEE
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: Y
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0		1999-06-02