MAUDE Adverse Event Report: ZIMMER BIOMET, INC. KNE-UNKNOWN-TIBIAL TRAY; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Pain (1994); Swelling (2091); Reaction (2414)

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.Additional associated products and mdrs: 42500006001 femur cemented posterior stabilized narrow left size 6 lot# 64491943, mdr: 3007963827-2020-00338.

Event Description

It was reported that patient underwent left total knee arthroplasty.Subsequently, patient has experienced pain, swelling and itching.Suggested allergy testing indicates patient is highly reactive to nickel and mildly reactive to zirconium and cobalt.

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.Part and lot identification are necessary for review of device history records, neither were provided for the tibial component.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: allergy testing indicates patient is highly reactive to nickel and mildly reactive to zirconium and cobalt.The event is confirmed.A definitive root cause cannot be determined for the tibia tray implant as implant identification is unknown.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: KNE-UNKNOWN-TIBIAL TRAY
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11078219
• MDR Text Key: 223808846
• Report Number: 0001822565-2020-04218
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KNE-UNKNOWN-TIBIAL TRAY
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 59