MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TRABECULAR METAL TWO-PEG POROUS TIBIAL TRAY LEFT SIZE D; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration (4003)

Patient Problems Fall (1848); Failure of Implant (1924); Pain (1994)

Event Date 03/02/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products - persona cruciate retaining narrow porous femoral component catalog #: 42502206401 lot #: 65313218, persona medial congruent articular surface left 10mm catalog #: 42512100510 lot #: 64389189.Report source: event occurred in japan.The complainant has not yet indicated whether the product will 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 knee arthroplasty revision to address tibial plate subsidence after a fall and pain approximately one (1) month post-operatively.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being filed to correct information.

Event Description

It was reported that the patient underwent a knee arthroplasty revision to address tibial plate subsidence after a fall and pain approximately one (1) month post-operatively.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records received confirmed periprosthetic fracture adjacent to the lateral tibial component with resultant abnormal alignment of the hardware in the proximal tibia and valgus alignment of the knee, which may have been caused by a fall or trauma.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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

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

• Brand Name: PERSONA TRABECULAR METAL TWO-PEG POROUS TIBIAL TRAY LEFT SIZE D
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16627118
• MDR Text Key: 312115306
• Report Number: 0001822565-2023-00781
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024510531
• UDI-Public: (01)00889024510531(17)320723(10)65526113
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 42530006701
• Device Lot Number: 65526113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 03/22/2023; 06/02/2023
• Supplement Dates FDA Received: 04/12/2023; 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2022
• 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 Sex: Prefer Not To Disclose
• Patient Weight: 78 KG