MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE E; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(4): 00111214001 - palacos r 1x40 single - 87524706, 42540000032 - all poly patella cemented 32 mm diameter - 63940183, 42500006002 - femur cemented posterior stabilized (ps) - 63819645, 42521400710 - articular surface fixed bearing posterior stabilized (ps) - 63844848.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the 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 filed for this event, please see associated reports: 0001822565-2020-01201.

Event Description

It was reported that the patient underwent a right knee revision approximately 19 months post implantation due to pain and loosening at the cement interface.It was also noted the patient suffered from a hairline fracture.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g4; g7; h1; h2; h3; h6.No devices or photographs were received; therefore the condition of the components is unknown.The dhr was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE E
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9904357
• MDR Text Key: 187367795
• Report Number: 0001822565-2020-01200
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024471061
• UDI-Public: 00889024471061
• Combination Product (y/n): N
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• 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: 42532007102
• Device Lot Number: 63776398
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR