MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PERSONA TIBIAL INSERT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2023

Event Type  malfunction  

Event Description

It was reported that during a total knee arthroplasty the surgeon could not get the articular surface to seat on the tibial tray.A second tibial insert was tried, and it was able to seat after gentle impaction with a mallet.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

Cmp-(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2023-00129.Concomitant medical products: unknown persona femoral catalog#: ni, lot#: ni.Tibia cemented 5 degree stemmed right size c catalog#: 42532006402, lot#: 65392341.G2 foreign source: japan.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported on 3007963827-2023-00165.

Event Description

Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported on 3007963827- 2023-00165.

• Brand Name: UNKNOWN PERSONA TIBIAL INSERT
• 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: 16941061
• MDR Text Key: 315460728
• Report Number: 0001822565-2023-01313
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• 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
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SEE H10