MAUDE Adverse Event Report: BIOMET SPAIN, S.L. TNBN POL COCR FIN TIB TRAY 67; PROSTHESIS KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Swelling/ Edema (4577)

Event Date 10/01/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: cr-interlok femur anatomic right 62,5mm titan niob, ref.183006tnbn, lot unk.Dcm cr 10mm x 63/67mm, ref.Unk, lot unk.Report source: this prodcut 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 (b)(4) manufactures a similar device that is cleared or distributed in the united states under 510 (k) number k945028.Remains implanted.

Event Description

Clinical study reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2012.Subsequently, the patient experienced swelling and decreased mobility of the operated knee.Knee mobilization was performed under anaesthesia on (b)(6) 2012.

Manufacturer Narrative

(b)(4).D10: associated products: cr-interlok femur anatomic right 62,5mm titan niob ref.(b)(4) lot unk; dcm cr 10mm x 63/67mm ref.(b)(4) lot unk.G4: this prodcut 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.Additional information received: ref.(b)(4); lot.Unk.The complaint is going to be closed due to the lack of information (lot number has not been provided and product has not been returned).Therefore, it has not been possible to perform an investigation.If any additional information becomes available, then the complaint will be reopened and investigated accordingly, and subsequently a supplemental report will be provided where deemed required.H3 other text: remains implanted.

Event Description

Clinical study reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2012.Subsequently, the patient experienced swelling and decreased mobility of the operated knee.Knee mobilization was performed under anaesthesia on (b)(6) 2012.

• Brand Name: TNBN POL COCR FIN TIB TRAY 67
• 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: 12274258
• MDR Text Key: 264962915
• Report Number: 0009610576-2021-00008
• 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,study
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• 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: 141252TNBN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 07/27/2021
• 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): Other
• Patient Age: 58 YR
• Patient Weight: 95