MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Information (3190)

Event Date 12/25/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.All explanted devices were returned, and cement was found on the tibia, and wear on the articular surface.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Per package inserts: wear and loosening are known adverse effect of this system.The wear in the poly might cause the tibia to loose as stated in the reported event.However, sufficient information was not provided to identify the cause of the articular surface wear.Therefore, a definitive root cause cannot be determined.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.Concomitant medical products: 42522200613, articular surface, lot # 63057860; 42502806802, femur, lot # 63351597.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00727.

Event Description

It was reported that the patient underwent a revision of the knee due to tibial loosening and poly wear.Attempts have been made and no further information has been provided.

• Brand Name: TIBIA CEMENTED 5 DEGREE STEMMED RIGHT
• 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: 9167200
• MDR Text Key: 161565200
• Report Number: 3007963827-2019-00287
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024471108
• UDI-Public: (01)00889024471108
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• 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: 42532007902
• Device Lot Number: 63656203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR