MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF TIBIA CEMENTED T4 LM; KNEE ENDOPROSTHETICS

Model Number	NO188Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/12/2021
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 no188z-as univation xf femur cemented f4 lm.According to the complaint description, the univation x no188z and no165z implants have loosened.No cement adhesion can be observed on the implants.A revision surgery was necessary.Additional information was not provided nor available / was not available.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00114 (400502135 no188z), 9610612-2021-00115 (400502136 no165z).Involved components (aufführen in d11 + c2) nl479-univation f meniscal comp.T4 rm/lm 8mm-52462745.
Additional Manufacturer Narrative
Investigation results: visual investigation: the femoral-as well as the tibial component show no device failure or serious damage.The components were examined visually and microscopically.In the delivered condition the tibial as well as the femoral component show no bone cement adhesive on the intended area.The surgery report from the revision operation also mentions that neither the femoral nor tibial component was covered with bone cement.The coated surface of both implants shows no abnormal deviations failure.The visible discoloration of both implant surfaces is a result of oxidation and does not affect the material properties in any way.The meniscal component shows only little imprints and scratches.The provided x-ray figures give no hints regarding the root cause for the mentioned implant loosening.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 the risk assessment revealed that the overall risk level (severity x probability of occurrence) according to din en iso 14971 is no longer acceptable.The need to revisit the risk assessment will be requested and further evaluated by the responsible department.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.Different scenarios can lead to the loosening of the implant.Based upon the investigations results a product safety case was initiated.Any action regarding capa will be addressed with this case.
Event or Problem Description
Associated medwatch-reports: 9610612-2021-00114 ((b)(4)no188z); 9610612-2021-00115 ((b)(4)no165z).Involved components (aufführen in d11 + c2).Nl479-univation f meniscal comp.T4 rm/lm 8mm-52462745.

• Brand Name: AS UNIVATION XF TIBIA CEMENTED T4 LM
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11426347
• Report Number: 9610612-2021-00114
• Device Sequence Number: 2855152
• Product Code: HRY
• UDI-Device Identifier: 04046964053658
• UDI-Public: 4046964053658
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K131167
• 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: Physician
• Remedial Action: Recall,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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: NO188Z
• Device Catalogue Number: NO188Z
• Device Lot Number: 52555913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 03/07/2021
• Supplement Report FDA Received Date: 04/23/2021
• 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: NL479-52462745.; NL479-52462745.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR