MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN NEXGEN MONOBLOCK TIBIA; PROSTHESIS, KNEE

Model Number N/A

Device Problems Fracture (1260); Unstable (1667)

Patient Problem Insufficient Information (4580)

Event Date 01/03/2024

Event Type  Injury  

Event Description

It was reported that the patient underwent a knee arthroplasty revision to address post-operative implant breakage of the monoblock tibia and instability.Attempts have been made; however, no additional information is available.

Manufacturer Narrative

(b)(4).D10 - concomitant devices - unknown nexgen femoral component catalog #: ni lot #: ni.The complainant has indicated that the product will not be returned to zimmer biomet for investigation due to an implant study.The investigation is in process.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.

Event Description

It was reported that the patient underwent a left knee arthroplasty revision to address post-operative implant breakage of the monoblock tibia and instability approximately sixteen (16) years post-operatively.Initial operative notes provided noted no intraoperative complications.Attempts have been made; however, no additional information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of pictures provided confirmed the post feature of the articular surface had fractured off.The device history records could not be reviewed as the lot number associated with the reported event is unknown.A definitive root cause could not be determined with the information provided.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.

• Brand Name: UNKNOWN NEXGEN MONOBLOCK TIBIA
• 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: 18595515
• MDR Text Key: 333966372
• Report Number: 0001822565-2024-00242
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• 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,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: Yes
• 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: 03/12/2024
• 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 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female