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

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 06/07/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).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 (b)(4) manufactures a similar device that is cleared or distributed in the united states under 510(k) number k945028.Associated products: reference: (b)(4); lot 759930; description vanguard as 10mm poly.

Event Description

It was reported that the patient underwent a revision surgery on (b)(6) 2022 due to subsidence.No further information has been received.

Event Description

Revision due to subsidence.

Manufacturer Narrative

(b)(4).Follow-up report including new information for fields: g1-2 (email address), g6 and h6 (investigation conclusion).

• 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
• Manufacturer (Section G): BIOMET SPAIN, S.L.; calle islas baleares, #50; p.o. box 96; fuente del jarro, valencia 46988 ; SP 46988
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14905604
• MDR Text Key: 295231681
• Report Number: 0009610576-2022-00004
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 141252
• Device Lot Number: 2021041410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2021
• 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
• Patient Outcome(s): Required Intervention