MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VAN PS OPEN INTL FEM-LT 67.5; PROSTHESIS KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Erosion (1750); Pain (1994); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 01/25/2021

Event Type  Injury  

Manufacturer Narrative

Product location unknown.

Event Description

It was reported patient underwent a revision procedure one year post implantation due to pain, swelling, instability and a popping sensation in the knee.Attempt for further information has been made, but no further information has been provided.

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: suggested code: mechanical g4- femur.Reported event was confirmed by review of medical records provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Medical records review indicates initial surgery notes or x-ray found no complications.The patient had history of fall due to dizziness but not related to knee implants.The patient reported that the knee area feels warm to touch.Additionally, patient was noted with malrotation, pain, swelling and instability.During the revision surgery, significant anterior notch was found noted and femur component was upsized.The implants were revised without complication.Patella was retained.Post op x-ray noted lucency adjacent to the femoral prosthesis not thought to be a fracture.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: VAN PS OPEN INTL FEM-LT 67.5
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15476603
• MDR Text Key: 300576253
• Report Number: 0001825034-2022-02207
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00880304270916
• UDI-Public: (01)00880304270916(17)290729(10)J6566364
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• 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: 183130
• Device Lot Number: J6566364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2019
• 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 Sex: Male
• Patient Weight: 89 KG