MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE GMBH 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 visual evaluation showed that two of the upper bolts were loose.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 information provided by the customer the bolts were loose.No fall, no injuries.

• Brand Name: MODULAR POLYCENTRIC EBS KNEE JOINT
• Type of Device: MODULAR POLYCENTRIC EBS KNEE JOINT
• Manufacturer (Section D): OTTO BOCK HEALTHCARE GMBH; max-naeder-str. 15; duderstadt, 37115 ; GM 37115
• Manufacturer (Section G): OTTO BOCK HEALTHCARE GMBH; max-naeder-str. 15; duderstadt, 37115 ; GM 37115
• Manufacturer Contact: dominik schmidt ; max-naeder-str. 15; duderstadt, niedersachsen 37115 ; GM 37115
• MDR Report Key: 9817262
• MDR Text Key: 182983344
• Report Number: 9616494-2018-00071
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 3R60
• Device Catalogue Number: 3R60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Date Manufacturer Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2018
• 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