MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD SSK PSC TIB BRG 12X63/67; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Upon experiencing instability, osteoarthritis, and recurvatum, this patient received a left total knee arthroplasty.During this procedure, the patient was outfitted with a zimmer biomet total knee construct consisting of a stem, a femur, a constrained dcm tibial bearing, and a fixed cruciate tibial tray.The distal femoral resection was performed using a 6 degree valgus guide and the surgeon elected to use a 12mm constrained tibial bearing as the construct exhibited excellent range of motion as well as stability through range of motion, no liftoff, and good patellar tracking.However, following the initial surgery, the patient noted continued pain and instability.Upon inspection of the x-rays, dr.(b)(6) observed a considerable posterior inferior slope of the patient¿s indwelling tibia and noted looseness of the knee during extension.In order to treat this patient, dr.(b)(6) would like to correct the noted slope and flexion issues with a custom poly tibial bearing.Additionally, the surgeon would like to retain the indwelling distal femur and fixed cruciate tibial tray to avoid potential soft tissue damage and/or bone loss in the event the aforementioned implants were to be removed.Therefore, dr.(b)(6) has requested a set of custom posterior sloped tibial bearings (one with a 16mm thickness, one with a 20mm thickness; two different thicknesses for intraoperative flexibility) in order to mate with the indwelling indicated implants and correct the patient¿s posterior inferior tibial slope and instability issues to ensure reduced pain and future mobility.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.The reported products were reviewed for compatibility with no issues noted.Review of complaint history identified no additional similar complaints for the reported item.However, as the lot number is unknown, an additional review could not be performed.Medical records were not provided.This complaint was not confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.

Event Description

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

• Brand Name: VNGD SSK PSC TIB BRG 12X63/67
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11877942
• MDR Text Key: 252687215
• Report Number: 0001825034-2021-01593
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

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: 183862
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 09/21/2021
• Supplement Dates FDA Received: 09/23/2021
• 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