MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OSS MODULAR PROXIMAL TIBIA 9CM 63MM STANDARD; PROSTHESIS, KNEE

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.(b)(4).The device was not returned, however, other samples and manufacture records were reviewed and the labeling discrepancy of the label containing 'avl' when it is a standard component was confirmed; the actual device was manufactured to specification and would still be compatible with standard or avl oss components.Corrective action has been initiated to address the reported issue.

Event Description

It was reported that the label of the modular proximal tibia has a discrepancy in the description.

Manufacturer Narrative

This complaint is recorded with zimmer biomet under (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Review of the dhr found a related anomaly:and the labeling discrepancy of the label containing 'avl' when it is a standard component was confirmed; the actual device was manufactured to specification and would still be compatible with standard or avl oss components.Investigation results concluded that the reported event was due to an error in the global label process.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that he label of the modular proximal tibia has a discrepancy in the description.Additional information received noted the device was not needed and the procedure was completed without delay.

• Brand Name: OSS MODULAR PROXIMAL TIBIA 9CM 63MM STANDARD
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6251903
• MDR Text Key: 64896655
• Report Number: 0001825034-2017-00181
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK083827
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CP113462
• Device Lot Number: 539760
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1