MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR ILOK FEM-LT 60; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); No Code Available (3191)
Date of Event	03/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Please see associated: 0001825034 - 2019 - 01660, 0001825034- 2019- 02871.Report source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Remains implanted.
Event or Problem Description
It was reported the patient underwent a manipulation under anesthesia to address knee stiffness and limited range of motion.No further information is available at this time.
Event or Problem Description
No further information is available at this time.
Additional Manufacturer Narrative
- no product was returned or pictures provided; visual and dimensional evaluations could not be performed.- device history record (dhr) review was performed with no related manufacturing deviations or anomalies identified.- the reported products were not compatible, an xp femur must be used with the xp tibial bearings.- joint assist findings identified the patient has undergone mua due to joint stiffness in left knee and rom limitation.- the incompatible implants might have contributed to the event, but a definitive root cause cannot be determined.- complaint is confirmed.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: VANGUARD CR ILOK FEM-LT 60
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9069616
• Report Number: 0001825034-2019-04076
• Device Sequence Number: 1748714
• Product Code: MBH
• UDI-Device Identifier: 00880304270497
• UDI-Public: 00880304270497
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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 Expiration Date: 12/26/2025
• Device Model Number: N/A
• Device Catalogue Number: 183024
• Device Lot Number: J3715590
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 12/06/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 195807 VGXP E1 TIB BRG, LOT 103750; 195877 VGXP TIB BRG, LOT 057080; 195807 VGXP E1 TIB BRG, LOT 103750; 195877 VGXP TIB BRG, LOT 057080
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 64