MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR ILOK FEM-LT 67.5; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: associated products : item#:ep-189102, e1 vngd as tib brg 12x79, lot#: 663800; item#:141225, biomet cc i-beam tray 79mm, lot#: j3682483; item#:184786, series a pat thn 34 3 peg, lot#: 445560.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is still implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00326, 0001825034 - 2021 - 00328, 0001825034 - 2021 - 00330.
Event or Problem Description
It was reported patient underwent initial left tka approximately 4.5 years ago.Patient underwent a revision 11 days later for infection.Patient states since having surgery, he has not been able to bend his knee all the way and is continually getting worse.Currently, patient is only able to bend his knee about 15%.He underwent physical therapy approximately 1 year ago for 6 weeks, but did not see improvement.
Additional Manufacturer Narrative
Reported event was confirmed by review of medical records noting patient presented to physician experiencing pain, difficult bending and climbing ladder.No revision has been reported to date.Dhr was reviewed and no discrepancies were found.The root cause is unable to 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
No further event information available at the time of this report.

• Brand Name: VANGUARD CR ILOK FEM-LT 67.5
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11269123
• Report Number: 0001825034-2021-00327
• Device Sequence Number: 16435446
• Product Code: JWH
• UDI-Device Identifier: 00880304270527
• UDI-Public: (01)00880304270527(17)260217(10)976380
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

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 Expiration Date: 02/17/2026
• Device Model Number: N/A
• Device Catalogue Number: 183030
• Device Lot Number: 976380
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 04/29/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 89