MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR ILOK FEM-LT 72.5; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Ambulation or Postural Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.Associated products : item#: 141224; biomet cc i-beam tray 75mm; lot#: j6028131; item#: 183440; vngd cr tib brg 10x71/75; lot#: 029780; item#: 00111214001; palacos r 1x40 single; lot#: 85214571; item#: 00111214001; palacos r 1x40 single; lot#: 85214571; item#: 184766; series a pat std 34 3 peg; lot#: 490480.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00169, 0001825034 - 2021 - 00170, 0001822565 - 2021 - 00218, 0001822565 - 2021 - 00219.
Event or Problem Description
It was reported that patient underwent left total knee arthroplasty approximately 3.5 years ago.Subsequently, patient has experienced pain, difficulty walking, rom issues and was told by surgeon that x-rays show movement and the bone cement looks unusual.Patient has underwent two manipulations, dates are unknown at this time.
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00169-1, 0001825034-2021-00170-1.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.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
No further event information available at the time of this report.

• Brand Name: VANGUARD CR ILOK FEM-LT 72.5
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11223489
• Report Number: 0001825034-2021-00168
• Device Sequence Number: 17079989
• Product Code: JWH
• UDI-Device Identifier: 00880304449183
• UDI-Public: (01)00880304449183(17)270222(10)J3980213
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: 183033
• Device Lot Number: J3980213
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 04/30/2021
• 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: Required Intervention
• Patient Weight: 82