MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL TIBIAL CEMENTED SIZE D LEFT MEDIAL; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 11/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Age: (b)(6).Concomitant medical products: 42558000601 62477806 partial femur cemented size 6 left medial, 42518200408 63449770 partial articular surface left medial size d 8 mm thickness.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due location of the device is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient¿s knee was revised approximately two years post implantation due to loosening of the tibial component, pain, fracture, and instability.Two year visit medical records noted patient experienced some problems with self-care, mobility and usual activities, severe pain, and knee has interfered with usual work moderately.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: PARTIAL TIBIAL CEMENTED SIZE D LEFT MEDIAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9478671
• MDR Text Key: 171582761
• Report Number: 0001822565-2019-05322
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00850304812666
• UDI-Public: (01)00850304812666
• Combination Product (y/n): N
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• 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: 42538000401
• Device Lot Number: 63607192
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2020
• 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: 104