MODULAR POLYCENTRIC EBS KNEE JOINT

Report

• Report Number: 9616494-2018-00069
• Event Type: Malfunction
• Date Received: March 11, 2020
• Report Date: July 3, 2018
• Manufacturer: OTTO BOCK HEALTHCARE GMBH
• Product Code: ISY
• Report Source: Manufacturer report
• Reporter Location: SP
• Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE VISUAL EVALUATION SHOWED THAT TWO OF THE UPPER BOLTS WERE LOOSE. THE PATIENT FELL BUT THERE WERE NO SERIOUS INJURIES SUSTAINED AS A RESULT OF THE FALL. NO MEDICAL TREATMENT WAS NEEDED.

Description of Event or Problem · 1

KNEE JOINT WAS SENT IN FOR REPAIR. ACCORDING TO INFORMATION PROVIDED BY THE CUSTOMER THE BOLTS WERE LOOSE. PATIENT FELL, BUT THERE WERE NO SERIOUS INJURIES SUSTAINED AS A RESULT OF THE FALL. NO MEDICAL TREATMENT WAS NEEDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
279181	MODULAR POLYCENTRIC EBS KNEE JOINT	MODULAR POLYCENTRIC EBS KNEE JOINT	ISY	OTTO BOCK HEALTHCARE GMBH	3R60

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• No Known Impact Or Consequence To Patient

Product problems · 1

• Mechanical Problem

Type of report · 1

• Initial submission