MAUDE Adverse Event Report: ZIMMER ORTH: KO, IMMOBILIZER

Device Problems Break (1069); Mechanical Jam (2983)

Patient Problems Damage to Ligament(s) (1952); Pain (1994)

Event Date 08/09/1996

Event Type  Injury  

Event Description

"defect work night -ship, the parts the got jammed-up.The machine is falling apart breaking metal bar.Working at home doing form/hang up and down, hand and mount, up and down heay wagon.Stepped wrong did it again that the end of the day, torn this ligament in leg.After i stop caring it, it still act up.When i get down on this floor the lower goes out and there's pain then go away until it happen again.Long time ago i fell five story down, and the back seat of the cop car, he had it pull back into my knee clamp up there, but that's a different story.Got t.V.".

• Brand Name: ORTH: KO, IMMOBILIZER
• Type of Device: ORTH: KO, IMMOBILIZER
• Manufacturer (Section D): ZIMMER; statesville NC 28677
• MDR Report Key: 5410213
• MDR Text Key: 37566221
• Report Number: MW5060004
• Device Sequence Number: 1
• Product Code: IQI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 36 YR
• Patient Weight: 88