MAUDE Adverse Event Report: AESCULAP AG AS VEGA PS FEMORAL COMP.CEMENTED F4N R; KNEE ENDOPROSTHESES

Model Number	NX029Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site 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 (b)(6) inc.That a as vega ps femoral comp.Cemented f4n r (part # nx029r) was implanted during a primary total knee arthroplasty (tka) procedure performed on (b)(6), 2018.According to the complainant, the device loosened 2 years and 6 months post surgery.The patient underwent a revision surgery.Upon removal, the femur exhibited very little cement bonding.The complaint device was discarded, therefore, it is not available to be returned to the manufacturer for evaluation.A revision surgery was necessary.The adverse event is filed under aag reference (b)(4).Involved components: nx110 - vega ps gliding surface t1/1+ 10mm - lot 52396660.Nx051z - as vega ps tibial plateau cemented t1 - lot 52424675.Nn261z - as tibial obturator d12mm - lot 52413272.
Event or Problem Description
The adverse event is filed under aag reference (b)(4) ((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: 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.Explanation and rationale, and root cause: according to the quality standard and device history records (dhr) a material defect and production error was not found.In the light of the small amount of information received and due to the circumstance that we did not receive the complained devices for investigation, it is not possible to determine a definitive root cause for the mentioned failure.It could be possible that there were problems with the cement technique.Corrective action for the topic of vega loosening, a product safety case (psc) was initiated.

• Brand Name: AS VEGA PS FEMORAL COMP.CEMENTED F4N R
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11673335
• Report Number: 9610612-2021-00316
• Device Sequence Number: 19596103
• Product Code: JWH
• UDI-Device Identifier: 04046963810122
• UDI-Public: 4046963810122
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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: NX029Z
• Device Catalogue Number: NX029Z
• Device Lot Number: 52402522
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 06/08/2021
• 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: NN261Z; NX051Z; NX110
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 59