MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD TI FEMORAL PS 65MM LT; PROSTHESIS KNEE

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Synovitis (2094); Osteolysis (2377); Reaction (2414); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical products: unknown tibial component catalog # unknown lot # unknown.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2020-03854.Remains implanted.

Event Description

It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient will be considered for revision due to allergies.Patient alleges to be allergic to zirconium and chromium.No revision procedure has been reported to date.Attempt for further information has been made, but no further information has been provided.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.D11: biomet ilok pri tib tray catalog # 141211 lot # 983340.Biomet finned pri stem 40mm catalog # 141314 lot # 530850.Vngd ps tib brg 11x63/67 catalog # 183621 lot # 649610.Series a asymmetric pat 31x8 catalog # 184792 lot # 711690.Simplex cement catalog # unknown lot # unknown.

Event Description

From additional information received, it was reported that the patient has indicated for revision due to metal allergies, pain, swelling, stiffness and synovitis.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

From additional information received, it was reported that the patient has indicated for revision due to metal allergies, pain, swelling, stiffness and synovitis.Also due to osteolysis, noise / clunking, loosening and migration.Further, office notes indicate that the leg is swollen at the end of the day causing it to be stiff.A baker's cyst pops out behind the knee causing sharp pain to the inside of the kneecap.

Manufacturer Narrative

Reported event was confirmed by review of medical records provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Medical records review indicates that metal allergy to mercury, nickel, tin, chromium, vanadium and zirconium.Popping and clunk with prosthesis.Femoral component is slightly rotated into flexion 5-10 degrees.Lytic lines along cement mantle, especially along femoral component.Mechanical loosening of the knee.X-rays show no evidence of hardware complication with mild join effusion and soft tissue swelling.Bone scan shows abnormal asymmetric uptake of radiopharmaceutical around the total knee hardware in the left knee.Most prominent around the femoral component with activity around the tibial component.By end of the day left leg is swollen causing the knee to be stiff.A bakers cyst pops out behind the knee by the end of the day causing sharp pain inside of the kneecap.Synovitis of the joint of the left knee likely due to reaction to the metals.No evidence of loosening and cultures are all negative.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 Description

No further event information available at the time of this report.

• Brand Name: VANGUARD TI FEMORAL PS 65MM LT
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10708841
• MDR Text Key: 212267392
• Report Number: 0001825034-2020-03853
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K080204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CP113639
• Device Lot Number: 390450
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 70