MAUDE Adverse Event Report: AESCULAP AG VEGA PS+ GLIDING SURFACE T3/3+ 10MM; KNEE ENDOPROSTHESIS

Model Number	NX230
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap inc.That a vega ps+ gliding surface t3/3+ 10mm (part # nx230) was implanted during a total knee replacement surgical procedure performed on an unknown date.According to the complainant, the screw for vega ps poly backed out and became loose in the joint.The patient underwent a revision procedure on (b)(6) 2021.The complaint device was returned to the manufacturer for evaluation.Followup information was received which confirmed that the device did not break; the screw backed out.The patient underwent a 25 minute scope procedure while under anesthesia to remove the screw.No patient complication were reported as a result of the event.The adverse event is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Investigation results: 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 no lot number was provided, a review of the device history records for the complained device is not possible.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.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 investigations results a capa is not necessary.
Event or Problem Description
No changes required.

• Brand Name: VEGA PS+ GLIDING SURFACE T3/3+ 10MM
• Common Device Name: KNEE ENDOPROSTHESIS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12025271
• Report Number: 2916714-2021-00119
• Device Sequence Number: 1374600
• Product Code: JWH
• UDI-Device Identifier: 04046963811242
• UDI-Public: 4046963811242
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2022
• Report Date (Section F): 06/18/2021

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: NX230
• Device Catalogue Number: NX230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 07/20/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/18/2021