MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PARTIAL TIBIAL CEMENTED; PROSTHESIS KNEE

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 08/09/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: partial femur cemented catalog # 42558000302 lot # 64730064.Partial articular surface catalog # 42528200410 lot # 64559122.Initial reporter name and address: (b)(6).

Event Description

It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient was revised due to pain and tibial fracture.Attempt for further information has been made, but no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.X-ray review indicates there is periprosthetic fracture of the medial tibial component of the hemiarthroplasty with resultant/malalignment of the joint.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable under this mfr number.This event will be reported under mdr # 0001825034-2022-00519.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable under this mfr number.This event will be reported under mdr # 0001825034-2022-00519.

• Brand Name: PARTIAL TIBIAL CEMENTED
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12406393
• MDR Text Key: 269304863
• Report Number: 3007963827-2021-00183
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K161592
• 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: 03/09/2022

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: 42538000402
• Device Lot Number: 64901375
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 09/13/2021; 03/03/2022
• Supplement Dates FDA Received: 09/16/2021; 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2020
• 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 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female