MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIA FIXED CEMENTED STEM EXTENSION; PROSTHESIS KNEE

Model Number N/A

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 07/19/2022

Event Type  Injury  

Event Description

It was reported patient underwent a revision procedure one years post implantation due to the tibial baseplate internally rotated.No further information is available.

Manufacturer Narrative

(b)(4).Concomitant medical products: tibial augment cemented half block right medial size ef 5 mm thickness catalog # 42555805405 lot # 64925185, tibial augment cemented half block right lateral size ef 5 mm thickness catalog # 42555805205 lot # 64661878, stem extension 3mm offset splined uncemented 15 mm diameter +135 mm length catalog # 42560313515 lot # 64716457, tibial central cone size x-small catalog # 42545000510 lot # 64910599, articular surface fixed bearing constrained posterior stabilized (cps) right 14 mm height use with tibia sizes e-f / ps femur sizes 10-11 catalog # 42522600814 lot # 64251352.Customer has indicated that the product will not be returned because requested but not returned by hospital.Once the investigation has been completed, a follow-up mdr will be submitted. .

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Visual evaluation of the device pictures shows signs of use.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Radiographs review indicates there is possible sign of early loosening, however, no migration nor internal rotation of the tibial component.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: TIBIA FIXED CEMENTED STEM EXTENSION
• 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: 15192819
• MDR Text Key: 297532408
• Report Number: 0001822565-2022-02314
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024562899
• UDI-Public: (01)00889024562899(17)310503(10)65016903
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

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: 42542007502
• Device Lot Number: 65016903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2022
• Initial Date FDA Received: 08/09/2022
• Supplement Dates Manufacturer Received: 08/15/2022
• Supplement Dates FDA Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• 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 Age: 4 MO
• Patient Sex: Male
• Patient Weight: 95 KG