MAUDE Adverse Event Report: OTTOBOCK SE & CO KGAA MODULAR POLYCENTRIC EBS KNEE JOINT

Model Number 3R60

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The evaluation showed, that 2 bolts are missing (top right and down left of posterior link).The anterior link is bent.The lower part is damaged and the head of the upper hydraulic is broken.No fall or injury occurred due to this failure, but it could have led to patient injury.

Event Description

Knee joint was sent in for repair.According to the information provided by the customer the bolt at top of side is missing.No fall, no injuries.

• Brand Name: MODULAR POLYCENTRIC EBS KNEE JOINT
• Type of Device: MODULAR POLYCENTRIC EBS KNEE JOINT
• Manufacturer (Section D): OTTOBOCK SE & CO KGAA; max-naeder-str. 15; duderstadt, 37115 ; GM 37115
• Manufacturer (Section G): OTTOBOCK SE & CO KGAA; max-naeder-str. 15; duderstadt, 37115 ; GM 37115
• Manufacturer Contact: dominik schmidt ; max-naeder-str. 15; duderstadt, 37115 ; GM 37115
• MDR Report Key: 9942557
• MDR Text Key: 192148933
• Report Number: 9616494-2020-00009
• Device Sequence Number: 1
• Product Code: ISY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3R60
• Device Catalogue Number: 3R60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1