MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF FEMUR CEMENTED F4 RM; KNEE ENDOPROSTHETICS

Model Number	NO183Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer investigation: 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 aesculap (b)(4) that an as univation xf femur cemented f4 rm (part # no183z) was implanted during a procedure performed on (b)(6) 2019.According to the complainant, the implant loosened.The patient will undergo a revision surgery.The complaint device has not been 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: 9610612-2021-00226 (b)(4) - no159z) involved components nl473 - univation f meniscal comp.T4 rm/lm 7mm - 52494281.
Event or Problem Description
Associated medwatch-reports: 9610612-2021-00235 (400505588 - no183z).9610612-2021-00226 (400505587 - no159z).Involved components nl473 - univation f meniscal comp.T4 rm/lm 7mm - 52494281.
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.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.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 product safety case was initiated.Any action regarding capa will be addressed with this case.A product recall was initiated in beginning of 2021.The devices were not marketed any longer.

• Brand Name: AS UNIVATION XF FEMUR CEMENTED F4 RM
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11598682
• Report Number: 9610612-2021-00235
• Device Sequence Number: 14509305
• Product Code: HRY
• UDI-Device Identifier: 04046964053603
• UDI-Public: 4046964053603
• 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: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2021

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 Model Number: NO183Z
• Device Catalogue Number: NO183Z
• Device Lot Number: 52481796
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 06/15/2021
• 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: NL473 - 52494281; NL473 - 52494281
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR