MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER UNICOMPARTMENTAL KNEE SYSTEM ARTICULAR SURFACE; PROSTHESIS KNEE

Model Number N/A

Device Problems Unstable (1667); Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); No Code Available (3191)

Event Date 09/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical products - unicompartmental knee system femoral component high flex precoat # 00584201502 lot # 62986139, unicompartmental knee system tibial component precoat # 00584200402 lot # 62967301.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-07279 and 0001822565-2017-07281.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.

Event Description

It was reported that the patient underwent a revision surgery approximately 2 years post initial knee surgery due to pain.

Manufacturer Narrative

Reported event was confirmed by review of operative notes and x-ray reviews.X-ray review indicates that the medial margin of the tibial component projects several millimeters medial to the medial margin of the native tibial plateau rather than overlying or overhanging the medial tibial plateau.The tibial component exhibits approximately 2° anterior slope rather than desirable posterior slope.There is a suggestion of subsidence of the tibial component anteriorly.Tibial component coronal alignment and femoral component alignment are unremarkable.The femoral component nears the tibial component suggesting possible wear thinning/wear of the polyethylene insert.Bone quality appears grossly normal.Thin linear radiolucency is present at the tibial component metal-bone interface anteriorly suspicious for loosening of the tibial component.Linear radiolucency at the femoral component metal-bone and metal-soft tissue interfaces favors rebound artifact.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.Per package insert unicompartmental knee pain, swelling, instability are known adverse effects of the tka procedure.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.

Event Description

It was reported that the patient underwent a uni-compartmental knee arthroplasty revision surgery approximately two (2) years post initial knee surgery due to pain, instability, and swelling.The patient was revised to a total knee arthroplasty.

• Brand Name: ZIMMER UNICOMPARTMENTAL KNEE SYSTEM ARTICULAR SURFACE
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6964799
• MDR Text Key: 89825758
• Report Number: 0001822565-2017-07280
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00584202408
• Device Lot Number: 62930002
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 32 YR
• Patient Weight: 93