MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET CC I-BEAM TRAY 67MM; PROSTHESIS, KNEE

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Migration (4003)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Cmp (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional mdrs have been submitted for this event --------------------------------------------------------------------- 183626 vngd ps tib brg 16x63/67mm lot# 293900.Mdr# 0001825034-2020-03592.Additional associated products ----------------------------------------- 183124 van ps open intl fem-lt 60 lot# j3655084, 183099 vanguard fem pegs set 2 lot# 579740, 184764 series a pat std 31 3 peg lot# 605430.

Event Description

It was reported that the patient underwent an initial knee arthroplasty.During this surgery, an implant was used.Approximately a month late, the rep was notified that this particular implant was recalled.Subsequently, the patient is being considered for a revision due to tibial loosening and subsidence.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Devices were not returned back for evaluation.Photographs provided show explanted femoral, tibia and bearing component.The tibial component shows significant bone growth on the device.Review of the device history record(s) identified no deviations or anomalies during manufacturing.No compatibility issues were seen.Review of complaint history for found no additional related issues for this item and the reported part and lot combination.Medical records provided were not provided.X-ray evaluation by third party hcp confirms that there was tibial loosening seen with subsidence and malposition resulting in knee varus alignment.Abnormal radiolucency reflecting osteolysis is also present at the medial femoral condyle however femoral fit is maintained but the tibial implant is loose.Osteopenia was also seen.Root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.This complaint is confirmed.

Event Description

No further event information available at the time of this report.

• Brand Name: BIOMET CC I-BEAM TRAY 67MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10567381
• MDR Text Key: 207965743
• Report Number: 0001825034-2020-03598
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 141222
• Device Lot Number: J3929490
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 10/15/2020; 01/20/2021
• Supplement Dates FDA Received: 11/10/2020; 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.; SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention