MAUDE Adverse Event Report: BIOMET SPAIN, S.L. POLISHED FINNED TIB TRAY 67MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 06/02/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).This product is manufactured by biomet (b)(4) orthopaedics, s.L.And is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet warsaw manufactures a similar device that is cleared or distributed in the united states under 510(k) number k945028.Product location unknowns.

Event Description

On (b)(6) 2021, the patient had a revision of a vanguard tibial knee implant.There was no cement bonding on the tibial plateau of the primary vanguard.A revision of a vanguard tibial knee implant.There was no cement bonding on the tibial plateau of the primary vanguard.No additional information.

Manufacturer Narrative

(b)(4).G5: this product is manufactured by biomet spain orthopaedics, s.L.And is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet warsaw manufactures a similar device that is cleared or distributed in the united states under 510(k) number k945028.

Event Description

On (b)(6) 2021, the patient had a revision of a vanguard tibial knee implant.There was no cement bonding on the tibial plateau of the primary vanguard.A revision of a vanguard tibial knee implant.There was no cement bonding on the tibial plateau of the primary vanguard.No additional information.

• Brand Name: POLISHED FINNED TIB TRAY 67MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET SPAIN, S.L.; calle islas baleares, #50; p.o. box 96; fuente del jarro, valencia 46988 ; SP 46988
• MDR Report Key: 12007238
• MDR Text Key: 256468714
• Report Number: 0009610576-2021-00004
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 141252
• Device Lot Number: 2012070081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/16/2021
• Supplement Dates Manufacturer Received: 06/02/2021
• Supplement Dates FDA Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention