MAUDE Adverse Event Report: BIOMET SPAIN, S.L. POLISHED FINNED 1 PIECE TIBIAL TRAY 71 MM COATED TINBN; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of birth: 1963.Implante date - unknown month and day in 2014.Event date and explant date: unknown month and day in 2017.Medical products: ref 183128tnbn lot unk tinbn coated vanguard femur 65mm.Ref ep-183640 lot unk vanguard tibial bearing 10mm x 71/75mm ps.Ref 184786 lot unk series a thn patella 3 pegs 34mm x 7.8mm.This prodcut is manufactured by biomet (b)(4) 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.Customer has indicated that the product wil not be returned because prodcut location is unknown.The investigation is in process.

Event Description

Left total knee arthroplasty performed on an unknown date in 2014.Subsequently, the patient was revised on an unknown date due to pain.It is unknown what products were revised.

Manufacturer Narrative

(b)(4).A2: date of birth: 1963.D6a: implant date - unknown month and day in 2014.B3 adn d6b: event date and explant date: unknown month and day in 2017.D11: medical products: ref: 183128tnbn, lot: unk, tinbn coated vanguard femur 65mm; ref: ep-183640, lot: unk, vanguard tibial bearing 10mm x 71/75mm ps; ref: 184786, lot: unk, series a thn patella 3 pegs 34mm x 7.8mm.G5: this product is manufactured by biomet sapin 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.H3: customer has indicated that the product wil not be returned because product location is unknown.The principal investigator of the clinical study has declined to provided additional information.The lot number in unknown.

Event Description

Left total knee arthroplasty performed on an unknown date in 2014.Subsequently, the patient was revised on an unknown date due to pain.It is unknown what products were revised.

• Brand Name: POLISHED FINNED 1 PIECE TIBIAL TRAY 71 MM COATED TINBN
• 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: 12238311
• MDR Text Key: 263846330
• Report Number: 0009610576-2021-00006
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 141253TNBN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2021
• 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
• Patient Age: 62 YR
• Patient Weight: 66