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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Damage to Ligament(s) (1952)

Event Date 02/25/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical products: vang mono finned stm tib 63x8 item # 166481 lot # 6287517.Mfr site: (b)(4).Customer has indicated that the product will not be returned because it was discarded.The investigation is in process.Multiple mdr reports were filled for this event: 0001822565-2021-00645.Discarded.

Event Description

It was reported the patient underwent a revision procedure to treat stretched out collateral ligaments resulting from a trip and fall.Implants remained intact and was being replaced with the zimmer rhk.Attempts have been made and no additional information has been provided.

Event Description

From additional information, it was reported that a trip fall is possibility for the stretched out ligament.

Event Description

It was further reported from additional information, that it was a soft tissue problem, rupture of the medical collateral ligament which meant it had gross instability.It had nothing to do with the implant coming out.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.The surgeon speculated the fall may have caused the ligament laxity.However, it is unknown whether the fall caused the ligament laxity or the ligament laxity caused the fall.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 Description

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

• Brand Name: VANGUARD CR ILOK FEM-RT 60
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11457064
• MDR Text Key: 239385980
• Report Number: 0001825034-2021-00673
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: K113550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 183004
• Device Lot Number: J3719666
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention