MAUDE Adverse Event Report: BIOMET SPAIN, S.L. BIOMET MODULAR TIBIAL SYSTEM - POLISHED FINNED 1 PIECE TIBIAL TRAY 75MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 04/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: ref: 183028, lot: j6828862; vanguard knee system, cr femoral - left 65 mm.Ref: 183442; lot: 393660; vanguard knee system cr tibial bearing 12mm / dcm arcorn 71/75mm.Ref: 3003940002-3; lot: a951bf2702; refobacin bone cement r.Report source: event occurred in uk.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.Device not returned.

Event Description

It was reported that a revision surgery took place on (b)(6) 2022 due to pain and swelling.

• Brand Name: BIOMET MODULAR TIBIAL SYSTEM - POLISHED FINNED 1 PIECE TIBIAL TRAY 75MM
• 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: 15656981
• MDR Text Key: 302251007
• Report Number: 0009610576-2022-00006
• 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,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 141254
• Device Lot Number: 2020031003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2022
• Initial Date FDA Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2020
• 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): Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female