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

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	01/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product location unknown.
Event or Problem 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 or Problem Description
No further event information available at the time of this report.
Additional 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
• Common Device Name: 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
• Report Number: 0001825034-2022-02207
• Device Sequence Number: 6020749
• Product Code: HRY
• UDI-Device Identifier: 00880304270916
• UDI-Public: (01)00880304270916(17)290729(10)J6566364
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 12/30/2022
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 89 KG