ZIMMER * 5242-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-06-02 for ZIMMER * 5242-01 manufactured by Zimmer.

Event Text Entries

[19074812] This pt had a left total knee replacement in 1986. She did well until 1990 when she fell and required a revision of this total joint. She presents now with severe medical instability with a valgus deformity on the left. She also has severe pain. She is admitted to this facility for a revision of the left total knee. Intraoperatively all components were removed and replaced.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 226054
• MDR Report Key: 226054
• Date Received: 1999-06-02
• Date of Report: 1999-04-30
• Date of Event: 1999-04-27
• Date Facility Aware: 1999-04-27
• Report Date: 1999-04-30
• Date Reported to Mfgr: 1999-04-30
• Date Added to Maude: 1999-06-10
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ZIMMER
• Generic Name: TOTAL KNEE COMPONENTS
• Product Code: GCZ
• Date Received: 1999-06-02
• Model Number: *
• Catalog Number: 5242-01
• Lot Number: 57645900
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 9 YR
• Implant Flag: Y
• Date Removed: Y
• Device Sequence No: 1
• Device Event Key: 219211
• Manufacturer: ZIMMER
• Manufacturer Address: P.O. BOX 708 WARSAW IN 46581 US
• 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	1. Hospitalization; 2. Required No Informationntervention	1999-06-02