MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN NEXGEN LPS FLEX MOBILE ARTICULAR SURFACE 12MM; PROSTHESIS, KNEE

Device Problems Fracture (1260); Unstable (1667)

Patient Problem Failure of Implant (1924)

Event Date 06/14/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).A2: year of birth: 1940.D10: medical product: unknown femoral component: catalog#ni, lot#ni; unknown tibial tray: catalog#ni, lot#ni.G2: foreign: germany.Diligence is in progress to determine whether the device is available for evaluation by zimmer biomet.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial total knee arthroplasty on an unknown date.Subsequently, on an unknown timeframe post-implantation, the patient presented to the clinic with multidirectional instability.A revision surgery was performed in which it was determined that the post of the polyethylene bearing had fractured.Due diligence is in progress for this event; to date no further information has been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h6; h10.This complaint is not confirmed.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Medical records were not provided.Root cause was unable to 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 at time of this report.

• Brand Name: UNKNOWN NEXGEN LPS FLEX MOBILE ARTICULAR SURFACE 12MM
• 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: 17316965
• MDR Text Key: 319020139
• Report Number: 0001822565-2023-01915
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female