MAUDE Adverse Event Report: AESCULAP AG VEGA KNEE IMPLANT; KNEE ENDOPROSTHETICS

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

Patient Problem Failure of Implant (1924)

Event Date 09/23/2022

Event Type  Injury  

Event Description

It was reported to aesculap inc.That a vega knee system (part # unknown) was implanted during a primary procedure performed approximately five (5) years ago by another surgeon.According to the complainant, postoperative loosening of the implant occurred.Reportedly, the cement did not adhere to the implants or the bone.The patient underwent a revision surgery on (b)(6) 2022.The complaint device was not returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision surgery.The adverse event / malfunction is filed under aic reference (b)(4).Associated medwatch report: (b)(4) (2916714-2022-00102) nx032z.(b)(4) (2916714-2022-00104 ) ae-qas-k521-56.

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

Investigation complete.

Manufacturer Narrative

Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.However, a picture of the implant was provided for analysis; an examination of the image revealed no connection/adhesive between cement and implant, and no cement connection/adhesive to the bone.The device history records (dhr) were reviewed for the available lot number; the device was found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: VEGA KNEE IMPLANT
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 15605357
• MDR Text Key: 301729000
• Report Number: 2916714-2022-00103
• Device Sequence Number: 1
• Product Code: OOG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2022,01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2022
• Distributor Facility Aware Date: 09/23/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention