MAUDE Adverse Event Report: BIOMET ORTHOPEDICS REGENEREX TIBIAL COMPONENTS - TIBIAL TRAY 71MM; PROSTHESIS, KNEE

Catalog Number 141273

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Damage to Ligament(s) (1952)

Event Date 02/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: e1 vanguard tibial bearing: catalog ep-189066, lot 663750.Biomet finned stem 40mm: catalog 141314, lot 465480.Vanguard right femur 70mm: catalog 167032, lot 3850747.Series a patella: catalog 184700, lot 279760.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-01493 and 0001825034-2017-01494.

Event Description

It was reported that the patient underwent a right knee revision approximately three months post implantation due to loosening caused by medial collateral ligament damage.The tibial tray, stem, and bearing were removed and replaced.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.Loosening of the tibial component with apparent subsidence of the lateral tibial tray.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.The root cause of the reported issue is attributed to the patient's condition as the mcl damaged caused the implants to loosen, however, it is unknown what caused the mcl damage.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: REGENEREX TIBIAL COMPONENTS - TIBIAL TRAY 71MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6395832
• MDR Text Key: 69616694
• Report Number: 0001825034-2017-01492
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK080361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 141273
• Device Lot Number: 091570
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR