MAUDE Adverse Event Report: BIOMET SPAIN, S.L. POLISHED FINNED TIB TRAY 71MM; PROSTHESIS, KNEE

Model Number N/A

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 01/12/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products.Associated products: vanguard cr ilok fem-rt 62.5 reference 183006 lot j6227614.Series a pat std 34 3 peg reference 184766 lot 41500.This product 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.Product partially remains implanted.

Event Description

New complaint received indicating that a patient went to hospital due to pain and after checking x-ray fixation pin/locking bar vanguard tibia was found dislocated.Fixation hook was broken.Immediate surgery followed performed on (b)(6) 2021.Only locking bar was removed, tibial tray and femur were left in situ.

Manufacturer Narrative

(b)(4).D9: product returned uncompleted, only returned the locking bar, the tibial tray remains implanted.D11: associated products: vanguard cr ilok fem-rt 62.5 reference (b)(4), lot j6227614; series a pat std 34 3 peg reference (b)(6), lot 41500.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.Initial mfr report number: 0009610576-2021-00001.

Event Description

Complaint received indicating that a patient went to hospital due to pain and after checking x-ray fixation pin/locking bar vanguard tibia was found dislocated.Fixation hook was broken.Immediate surgery followed performed on (b)(6) 2021.Only locking bar was removed, tibial tray and femur were left in situ.

• Brand Name: POLISHED FINNED TIB TRAY 71MM
• 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: 11191921
• MDR Text Key: 227928465
• Report Number: 0009610576-2021-00001
• 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: 05/24/2021

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 Model Number: N/A
• Device Catalogue Number: 141253
• Device Lot Number: 2018090737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 01/19/2021
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention