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

Model Number AE-QAS-K521-56

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

Patient Problem Failure of Implant (1924)

Event Date 08/29/2022

Event Type  Injury  

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

It was reported that there was an issue with an unspecified vega implant (ae-qas-k521-56).According to the complaint description, the knee implant(s) loosened approximately five years postoperatively.A total knee revision was required due to implant loosening.When the tibia and femur implants were removed, they easily backed out and had no cement residues.The patient was revised to a columbus knee system.The patient was noted to be stable after the procedure and without complications.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch reports: (b)(4) (9610612-2022-00279) ae-qas-k521-56.(b)(4) (9610612-2022-00291) ae-qas-k521-56.(b)(4) (9610612-2022-00292) ae-qas-k521-56.

Manufacturer Narrative

Investigation: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that neither an article number nor a lot number were provided, a review of the device history records must remain incomplete.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.If the device is returned in the future, an investigation will again be completed at that time.Regarding vega implant loosening, product safety cases (pscs) were initialted.

Event Description

Associated medwatch reports: (b)(4) (9610612-2022-00279) ae-qas-k521-56, (b)(4) (9610612-2022-00291) ae-qas-k521-56, and (b)(4) (9610612-2022-00292) ae-qas-k521-56.

• 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: 15503866
• MDR Text Key: 300787399
• Report Number: 9610612-2022-00291
• 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: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• 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
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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