HSS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-07-31 for HSS manufactured by Hosp For Special Surgery Biomechanics Dept.

Event Text Entries

[16620325] On 12/30/91, the subject total elbow replacement was implanted. On follow-up x-ray (dated 5/13/97), the axle that holds the ulnar and humeral components together was shown to be partially disengaged. On 5/14/97, the initial reporter notified co. On 7/2/97, the problem was corrected by revision surgery. The clip that holds the axle in place, as well as the humeral and ulnar components were left in situ. The axle, plastic bushing and plastic bearing were removed and replaced.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2436878-1997-00001
• MDR Report Key: 112095
• Report Source: 05
• Date Received: 1997-07-31
• Date of Event: 1997-07-02
• Date Mfgr Received: 1997-07-02
• Device Manufacturer Date: 1991-11-01
• Date Added to Maude: 1997-08-13
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 0
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HSS
• Generic Name: TOTAL ELBOW REPLACEMENT
• Product Code: KWJ
• Date Received: 1997-07-31
• Model Number: NA
• Catalog Number: NA
• Lot Number: NA
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: Y
• Implant Flag: Y
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 110059
• Manufacturer: HOSP FOR SPECIAL SURGERY BIOMECHANICS DEPT
• Manufacturer Address: 535 EAST 70 ST. NEW YORK NY 10021 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	1997-07-31