MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN POROUS UNCEMENTED FEMORAL COMPONENT SIZE G LEFT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Fall (1848); Failure of Implant (1924)

Event Date 11/30/2021

Event Type  Injury  

Event Description

It was reported that the patient underwent a left knee arthroplasty revision to address instability approximately seven (7) years post-operatively following a fall.Attempts have been made, however, no additional information is available.

Manufacturer Narrative

(b)(4).D10 - concomitant devices - nexgen prolong cr-flex articular surface 10mm catalog #: 00595204010, lot #: 62781565, nexgen stemmed precoat tibial component size 5 catalog #: 00598004701, lot #: 62772516, nexgen all poly patella size 35mm catalog #: 00597206535, lot #: 62785917.G2 - report source - foreign: event occurred in (b)(6).The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.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 patient; please see all reports associated with this event: 0001822565-2023-02661; 0001822565-2023-02662 h3 other text : investigation incomplete.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6 - component code - proposed code is mechanical (04) - femur.The device history records were reviewed and no discrepancies were identified.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: NEXGEN POROUS UNCEMENTED FEMORAL COMPONENT SIZE G LEFT
• 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: 17868396
• MDR Text Key: 324888548
• Report Number: 0001822565-2023-02661
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K041100
• 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
• Report Date: 01/25/2024

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: 65595201701
• Device Lot Number: 62732439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2023
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2014
• 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): Required Intervention; Hospitalization
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 82 KG