MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VAN PS OPEN INTL FEM-LT 70 70; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)
Date of Event	03/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog#: 183760 vngd ps+ tib brg 10x79/83mm, lot#: 211910, catalog#: 185651 bmt 360 tib lg cruciate wing, lot#: 460900, catalog#: 185205 bmt 360 tib tray 79mm, lot#: 057110, catalog#: 148303 bmt splined knee stm v2 13x80 80, lot#: 665260, catalog#: 185235 bmt 360 tib aug 79x10mm mm, lot#: 354800.The event is confirmed with x-rays received.Review of the x-rays found loose femoral implant that has malrotated with malalignment.Bone quality is osteopenic.There appears to be a paucity of femoral fixation cement which could contribute to femoral implant loosening.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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 or Problem Description
It was reported that the patient underwent a revision procedure approximately 2 years and 4 months post implantation due to femur loosening.No further event information available at the time of this report.

• Brand Name: VAN PS OPEN INTL FEM-LT 70 70
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11677310
• Report Number: 0001825034-2021-01109
• Device Sequence Number: 3099657
• Product Code: JWH
• UDI-Device Identifier: 00880304270923
• UDI-Public: (01)00880304270923(17)261202(10)J3910886
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K113550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/15/2021

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: 183132
• Device Lot Number: J3910886
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 113