MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK NEXGEN FEMORAL; PROSTHESIS, KNEE

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Fall (1848); Failure of Implant (1924); Pain (1994); Osteolysis (2377); Numbness (2415); Swelling/ Edema (4577)

Event Date 08/25/2020

Event Type  Injury  

Event Description

It was reported a patient has had two right knee arthroplasties.Approximately 12 years post implantation, the patient fell and the right knee twisted inward, landing on bilateral knees.Patient was seen in the office about a month after the reported fall with complaint of medial knee pain, osteolysis, mild swelling, and mild numbness.Eight months post office visit the patient underwent a revision with the findings of instability and aseptic loosening.All components were removed and a revision system was implanted without complication.

Manufacturer Narrative

(b)(4).The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs: unknown nexgen articular surface, mdr: 0001822565-2023-00970; unknown nexgen tibial, mdr: 0001822565-2023-00971.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Component code- suggested code: mechanical (g04) - femur no product or photograph were returned ; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Insufficient information provided to perform a compatibility check.Complaint history review cannot be performed without product identification.Office notes reported pain is medial and directly towards the knee cap on the left and reported mild swelling, numbness, tingling.X-ray review showed well fixed implants, no acute fracture or dislocation.Per case report form, osteolysis was captured on x-ray.Revision notes state that patient was revised due to instability and loosening and grossly found patient unstable on flexion and extension.No intra-op complications/events were noted.This complaint is confirmed through medical records (loosening, instability, osteolysis).Root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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: UNK NEXGEN FEMORAL
• 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: 16713977
• MDR Text Key: 313311733
• Report Number: 0001822565-2023-00969
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/11/2023
• Supplement Dates Manufacturer Received: 05/23/2023
• Supplement Dates FDA Received: 05/26/2023
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White