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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 10/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of birth: (b)(6).(b)(4).Concomitant medical products: persona partial femur cemented, catalog # 42558000601, lot # 63458359.Persona partial articular surface, catalog # 42518200709, lot # 63573598.Report source: (b)(6).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.Multiple mdr reports were filled for this event: 0001822565-2018-07102.Product location is unknown.

Event Description

It was reported that the patient underwent a left knee arthroplasty.Subsequently, the patient was revised due to infection.Femoral prosthesis and tibial prosthesis were infected.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

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

Manufacturer Narrative

Upon receipt of information received and 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 receipt of information received and 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: PERSONA PARTIAL TIBIAL CEMENTED
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8199124
• MDR Text Key: 131488630
• Report Number: 0001822565-2018-07107
• 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,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• 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: 42538000701
• Device Lot Number: 63607194
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2019
• 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
• Patient Age: 82 YR
• Patient Weight: 116