MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF TIBIA CEMENTED T3 LM; KNEE ENDOPROSTHESES

Model Number	NO164Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap ag that an as univation xf tibia cemented t3 lm (part # no164z) was implanted during a primary procedure performed on (b)(6) 2020.According to the complainant, following implantation, the patient experienced pain.Radiographic and scintigraphic examination confirmed loosening of implant.The patient underwent a revision procedure on (b)(6) 2022 which revealed a complete loosening, both tibially and femorally, in the prosthesis/cement interface.So far, no evidence of infection.The complaint device was returned to the manufacturer for evaluation.A revision surgery was necessary.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: ((b)(4) - no164z), 9610612-2022-00038 ((b)(4) - no187z).Involved components: nl472 - univation f meniscal comp.T3 rm/lm 7mm - lot 52592618.
Additional Manufacturer Narrative
Investigation results: visual investigation: the available explants are in an undamaged condition and show no serious abnormalities or deviations.The components were examined visually and microscopically with the digital microscope.In the delivered condition the femoral component shows only partly visible bone cement residues on the intended area/coated surface.These bone cement residues show only less bone anchorage (cement interlock into the bone trabeculae).The provided tibial component shows almost no bone cement residues on the intended area/ coated surface.The discolorations on the surfaces of the implants are due to oxidation.Such changes in color have no effect on the function or properties of the coating.The gliding surface of the meniscal component shows visible scratches and imprints.The visible imprints probably resulting from third body wear (bone chips and/or bone cement residues).The provided x-ray figures give no detailed hints regarding the origin root cause for the 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 risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 4(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.Based upon the investigations results a product safety case and field safety corrective action (psc (b)(4) / fsca (b)(4); fsca (b)(4)) were initiated.

• Brand Name: AS UNIVATION XF TIBIA CEMENTED T3 LM
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 13654593
• Report Number: 9610612-2022-00037
• Device Sequence Number: 2304503
• Product Code: HRY
• UDI-Device Identifier: 04046964053757
• UDI-Public: 4046964053757
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K131167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2022

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: NO164Z
• Device Catalogue Number: NO164Z
• Device Lot Number: 52594567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NL472 - LOT 52592618
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female