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

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Osteopenia/ Osteoporosis (2651)

Event Date 01/15/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs; 183468 vngd cr tib brg 18x79/83 lot# 019770; mdr: 0001825034-2024-00299.Additional associated products: 185290 vngd ssk 360 l fem 80mm lot# 6495422; 148328 bmt splined knee stm v2 14x160 lot# 400340; 185410 vg 360 dst fm ag 80x10 ll/rm lot# 082110; 185390 vg 360 dst fm ag 80x10 rl/lm lot# 606040.

Event Description

It was reported the patient was revised for pain, effusion, and suspected implant loosening, with radiolucency noted around the femoral component.The femoral implant and articular surface were revised.

• Brand Name: VANGUARD CR POR FMRL-LT 72.5
• Type of Device: 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: 18640925
• MDR Text Key: 334554892
• Report Number: 0001825034-2024-00298
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 183073
• Device Lot Number: 454790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male