MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OXFORD FIXED LATERAL PARTIAL KNEE CEMENTED TIBIAL CONSTRUCT SIZE F3, RIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Tissue Damage (2104)

Event Date 09/13/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.

Event Description

During a right partial knee arthroplasty, it was noticed that the tibial component labeled as a right was actually a left; the surgeon had to recut the tibia to use a different size tibial component.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Product was not returned so no product evaluation could be conducted, however the provided pictures confirm the event.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to manufacturing error.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.

• Brand Name: OXFORD FIXED LATERAL PARTIAL KNEE CEMENTED TIBIAL CONSTRUCT SIZE F3, RIGHT
• 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 drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6024552
• MDR Text Key: 57248832
• Report Number: 0001825034-2016-04089
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: PK133940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 154375
• Device Lot Number: 744260
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0956-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention