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

Model Number	NX130
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/15/2021
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 nx130 - vega ps gliding surface t3/3+ 10mm.According to the complaint description, this patient presented to orthopaedic clinic 8 months post op reporting that she heard a pop in her knee while ambulatory.X ray found that the vega polyethylene insert set screw had backed out completely and was free floating in the knee joint.Surgery was scheduled.Surgeon retrieved the screw , fully intact, and removed it along with the polyethylene component.A new polyethylene insert was implanted and a new set screw was fully seated in the polyethylene insert.The patient left the or with a fully functioning knee replacement.The surgeon used palacos g cement during the initial surgery which was (b)(6) 2020.A revision surgery was necessary.Additional information was not provided nor available / was not available.The adverse event is filed under aag reference (b)(4).Involved components item code - description - batch nx043 - patella 3-pegs p3 - 52469178 nn261z - as tibial obturator d12mm - 52595742 nx055z - as vega ps tibial plateau cemented t3 - 52584296 nx032z - as vega ps femoral comp.Cemented f5r - 52277676 ae-qas-compet-imp - collect.No.Qas implants from competitors - unknown.
Additional Manufacturer Narrative
Updated h6: codes.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: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.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
Involved components.Nx043 - patella 3-pegs p3 - 52469178.Nn261z - as tibial obturator d12mm - 52595742.Nx055z - as vega ps tibial plateau cemented t3 - 52584296.Nx032z - as vega ps femoral comp.Cemented f5r - 52277676.Ae-qas-compet-imp - collect.No.Qas implants from competitors - unknown.

• Brand Name: VEGA PS GLIDING SURFACE T3/3+ 10MM
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11813933
• Report Number: 9610612-2021-00375
• Device Sequence Number: 3161087
• Product Code: JWH
• UDI-Device Identifier: 04046963810887
• UDI-Public: 4046963810887
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K101281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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 Expiration Date: 09/04/2024
• Device Model Number: NX130
• Device Catalogue Number: NX130
• Device Lot Number: 52550272
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AE-QAS-COMPET-IMP - UNKNOWN; AE-QAS-COMPET-IMP - UNKNOWN; NN261Z - 52595742; NN261Z - 52595742; NX032Z - 52277676; NX032Z - 52277676; NX043 - 52469178; NX043 - 52469178; NX055Z - 52584296; NX055Z - 52584296
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 86