KNEE PROSTHESIS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-13 for KNEE PROSTHESIS manufactured by Orthopedic Services.

Event Text Entries

[4123] Resident's right above the knee prosthesis came apart at the wood plate to 4 wood screw junction. Resident was ambulating with bilateral prosthesis when the right one broke. Resident was not injured secondary to being supported by pta, and a gait belt. Resident was then placed in his wheelchair. Device not 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: actual device involved in incident was evaluated, visual examination. Results of evaluation: inadequate quality assurance, manufacturing, invalid data. Conclusion: device failure directly caused event, device failure directly contributed to event, device was out of spec in a manner that relates to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor, other. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6559
• MDR Report Key: 6559
• Date Received: 1993-08-13
• Date of Report: 1993-08-11
• Date of Event: 1993-08-05
• Date Facility Aware: 1993-08-05
• Report Date: 1993-08-11
• Date Reported to FDA: 1993-08-11
• Date Added to Maude: 1993-09-28
• 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: 0
• Initial Report to FDA: 0
• 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: KNEE PROSTHESIS
• Generic Name: NA
• Product Code: ISS
• Date Received: 1993-08-13
• Model Number: NA
• Catalog Number: NA
• Lot Number: NA
• ID Number: NA
• Operator: OTHER CAREGIVERS
• Device Availability: Y
• Device Age: 01-JUN-93
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 6246
• Manufacturer: ORTHOPEDIC SERVICES

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-08-13