MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL TIBIAL CEMENTED; PROSTHESIS KNEE

Model Number N/A

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Failure of Implant (1924)

Event Date 04/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: medical "deices": partial femur cemented size 5 left medial item # 42558000501 lot # unknown; psn pk ve ply lm sz f 9mm item # lot # unknown; palacos r +g 2x40 g item # unknown lot # 66017569.Mfr site: (b)(4).Customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product location is unknown.

Event Description

It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient was revised due to aseptic tibia loosening.Attempt for further information has been made, but no further information has been provided.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined that this report is a duplicate of 0001825034-2020-04323.This event is not reportable.

Event Description

Upon reassessment of the reported event, it was determined that this report is a duplicate of 0001825034-2020-04323.This event is not reportable.

• Brand Name: PERSONA PARTIAL TIBIAL CEMENTED
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11467414
• MDR Text Key: 239390621
• Report Number: 0001825034-2021-00722
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• 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: 42538000601
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2021
• 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 Age: 56 YR