P-BONE CEMENT SURGICAL SIMPLEX P 6191-1-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-22 for P-BONE CEMENT SURGICAL SIMPLEX P 6191-1-001 manufactured by Howmedica International Ltd.

Event Text Entries

[3744] Patient was undergoing an "open reduction internal fixation" of right hip when she went into cardiac arrest. Appropriate medication and response measures were taken and the patient responded well. The orthopedic procedure was completed and the patient was transferred to icu. Patient was discharged seven days later. Other relevant devices in use at the time of incident included: hip prosthesis; i. E. , no 3 hip fracture stem, no. 3 finestrated plug, centrax bipolar (32 mm x 48 mm), and universal plug. 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 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: invalid data. Corrective actions: none or unknown. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6793
• MDR Report Key: 6793
• Date Received: 1993-07-22
• Date of Report: 1993-01-14
• Date of Event: 1992-12-31
• Date Facility Aware: 1992-12-31
• Report Date: 1993-01-14
• Date Reported to Mfgr: 1992-12-31
• Date Added to Maude: 1993-10-15
• 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: P-BONE CEMENT SURGICAL SIMPLEX P
• Generic Name: METHYL METHYCRYLATE MONOMER
• Product Code: JDY
• Date Received: 1993-07-22
• Catalog Number: 6191-1-001
• Lot Number: RJZ263 & RKZ282
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Device Age: 01-DEC-92
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 6476
• Manufacturer: HOWMEDICA INTERNATIONAL LTD

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-07-22