MAUDE Adverse Event Report: AESCULAP AG VEGA PS TIBIAL PLATEAU CEMENTED T1; KNEE ENDOPROSTHESES

Model Number	NX051K
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
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 nx051k - vega ps tibial plateau cemented t1.According to the complaint description, early loosening (x-ray symptoms less than 3 years old).Pain in the patient two years after the operation.Patient operated on 2017; reoperation in (b)(6) 2021 due to early pain symptoms resulting from loosening of the tibial endoprosthesis.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).Associated medwatch-reports: nr (cc + item code).9610612-2021-00450 ((b)(4) + nx009k).Involved components: nx110 - vega ps gliding surface t1/1+ 10mm - 52206779.
Additional Manufacturer Narrative
Investigation results/ visual investigation: the tibial component arrived in a clean status with no bone cement adhesion.The femoral component arrived with bone cement residues adhesion.The gliding component arrived in a clean status with visible damage.The investigation was carried out visually and microscopically.The available tibial component and femoral component show no abnormalities or serious visible damages.There are only bone cement residues on the femoral component in the current situation.The are no bone cement residues on the tibial component.The gliding component shows visible damage, marks and scratches.Based on the current information, a clear conclusion cannot be drawn.There are no hints for a material problem.It could be possible that there were problems with the cement technique.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.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.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.
Event or Problem Description
Associated medwatch-reports: 9610612-2021-00449 ((b)(4) + nx051k) and 9610612-2021-00450 ((b)(4) + nx009k).Involved components: nx110 - vega ps gliding surface t1/1+ 10mm - 52206779.

• Brand Name: VEGA PS TIBIAL PLATEAU CEMENTED T1
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11959128
• Report Number: 9610612-2021-00449
• Device Sequence Number: 3741993
• Product Code: JWH
• UDI-Device Identifier: 04046963810368
• UDI-Public: 4046963810368
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K101281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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: 12/31/2025
• Device Model Number: NX051K
• Device Catalogue Number: NX051K
• Device Lot Number: 52206778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 08/26/2021
• 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: NX110 - 52206779; NX110 - 52206779
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR