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

Model Number	AE-QAS-K521-56
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with the product ae-qas-k521-56 - collect.No.Qas knee implants vega.According to the complaint description, the specific medical devices at issue in this complaint are as follows: vega system 7-layer advanced surface coating; vega system femoral components; vega system tibial components; aesculap implant systems advanced surface technology.These designs are defective and have failed, resulting in harm to the plaintiff.This event resulted in a permanent impairment.Additional information was not provided nor available.The adverse event is filed under aag reference (b)(4).Involved components: ae-qas-k521-56 - collect.No.Qas knee implants vega - lot unknown, ae-qas-k521-56 - collect.No.Qas knee implants vega - lot unknown.
Additional Manufacturer Narrative
Investigation results: as of the date of this report the complaint product was not provided for investigation.The investigation was based upon analysis of historical data review.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The assessment for reportabililty for this adverse event was based on patient harm, permanent impairment.Conclusion/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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigation results, a capa is not required.

• Brand Name: COLLECT.NO.QAS KNEE IMPLANTS VEGA
• Common Device Name: 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: 17886110
• Report Number: 9610612-2023-00221
• Device Sequence Number: 6754306
• Product Code: OOG
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AE-QAS-K521-56 - LOT UNKNOWN; AE-QAS-K521-56 - LOT UNKNOWN; AE-QAS-K521-56 - LOT UNKNOWN; AE-QAS-K521-56 - LOT UNKNOWN
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown