MAUDE Adverse Event Report: BIOMET SPAIN, S.L. POLISHED FINNED 1 PIECE TIBIAL TRAY 67 MM COATED TINBN; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Loss of Range of Motion (2032); Scar Tissue (2060)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event date: unknown month and day in 2017.Implant date: unknown month and day in 2013.Concomitant devices: ref (b)(4) lot unk vanguard tibial bearing 14mm x 63/67mm ps; ref (b)(4) lot unk tinbn coated vanguard knee posterior stabilized - interlok femur 60mm.Report source - foreign: (b)(6).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.The complainant has indicated that the prduct will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.

Event Description

It was reported left total knee arthroplasty performed on an unknown date in 2013.Subsequently, the patient underwent an arthrolysis due to range of motion issues.Range of motion continued to be a problem after the arthrolysis, and the patient had a maquet osteotomy and patella baja.No product has been exchanged.No additional information at this time.

Event Description

It was reported left total knee arthroplasty performed on an unknown date in 2013.Subsequently, on an unknown date in 2017 the patient underwent an arthrolysis due to range of motion issues.Range of motion continued to be a problem after the arthrolysis, and the patient had a maquet osteotomy and patella baja.No product has been exchanged.Lot number and additional information have not been provided.

Manufacturer Narrative

(b)(4).B3: event date: unknown month and day in 2017.D6a: implant date: unknown month and day in 2013.D10: concomitant devices: ref: ep-183624, lot: unk, vanguard tibial bearing 14mm x 63/67mm ps; ref: 183124tnbn, lot: unk, tinbn coated vanguard knee posterior stabilized - interlok femur 60mm.G2: report source - foreign: belgium.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.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.In addition the lot number is unknown and the principal investigator of the study has declined to provided additional information.

• Brand Name: POLISHED FINNED 1 PIECE TIBIAL TRAY 67 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: 12237875
• MDR Text Key: 263926401
• Report Number: 0009610576-2021-00005
• 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?: Yes
• 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
• 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: 61 YR
• Patient Weight: 80