MAUDE Adverse Event Report: AESCULAP AG COLLECT.NO.QAS KNEE IMPLANTS VEGA; KNEE ENDOPROSTHETICS

Model Number AE-QAS-K521-56

Device Problems Compatibility Problem (2960); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Insufficient Information (4580)

Event Date 11/09/2021

Event Type  Injury  

Event Description

It was reported that there was an issue with ae-qas-k521-56 (unknown vega knee implant) via information received from mw5106451.According to the complaint description, there was complete loss of cement bonding to implant of right knee and normal function in left total knee.A revision surgery was required.The explant date was noted as on (b)(6) 2021.Additional information has been requested.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation: no product available.Therefore a failure investigation of the product is not possible.Batch history review: due to the fact that neither an article number nor a lot number was provided, a review of the device history records must remain incomplete.Explanation and rationale/conclusion and root cause: in the light of little information received and due to the circumstance that we did not receive the complained devices, it is not possible to determine a root cause for the mentioned failure.Corrective action: regarding (vega) implant loosening two product safety cases (psc) were opened.

• Brand Name: COLLECT.NO.QAS KNEE IMPLANTS VEGA
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 13585637
• MDR Text Key: 286643004
• Report Number: 9610612-2022-00045
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/23/2022

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
• Device Operator: Health Professional
• Device Model Number: AE-QAS-K521-56
• Device Catalogue Number: AE-QAS-K521-56
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2022
• Initial Date FDA Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention