MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF TIBIA CEMENTED T4 LM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	NO165Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
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 to aesculap inc.That a univation x unicondylar knee arthroplasty system was implanted during a primary surgery performed on an unknown date.According to the complainant, the patient underwent a revision surgery 1468 days after the primary surgery due to implant loosening.The device was not available to be returned to the manufacturer for evaluation.The surgeon provided additional information which revealed the following cement technique: "cement holes were drilled in both femur and tibia.Cement was applied with finger pressure to the bone and to the components.Tibial component impacted and excess cement cleared.Femoral component impacted and excess cement cleared.Trial surface was placed and knee brought into extension with tongue depressor for pressurization.Cement allowed to cure prior to placing final poly." no known patient complications following the revision surgery.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00997 ((b)(4)) involved components : nl473-univation f meniscal comp.T4 rm/lm 7mm-51976008.
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.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.The univation devices were affected in a recall initiated recently.
Event or Problem Description
Associated medwatch-reports: 9610612-2020-00997 ((b)(4)- no187z).Involved components: nl473-univation f meniscal comp.T4 rm/lm 7mm-51976008.

• Brand Name: AS UNIVATION XF TIBIA CEMENTED T4 LM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11253409
• Report Number: 9610612-2020-00986
• Device Sequence Number: 19610667
• Product Code: HRY
• UDI-Device Identifier: 04046964053764
• UDI-Public: 4046964053764
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2021

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 Expiration Date: 12/31/2024
• Device Model Number: NO165Z
• Device Catalogue Number: NO165Z
• Device Lot Number: 52108119
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 04/15/2021
• 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: NL473-51976008.; NL473-51976008.
• Outcome Attributed to Adverse Event: Required Intervention