MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF TIBIA CEMENTED T6 RM; KNEE ENDOPROSTHESES

Model Number	NO161Z
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.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that an as univation xf tibia cemented t6 rm (part # no161z) and an as univation xf femur cemented f5 rm (part # no184z) (ref.Mdr id 9610612-2021-00394) were implanted during a primary surgery performed on an unknown date.According to the complainant, during the planned inlay change, it turns out that the tibial component (part # no161z) and the femoral component (part # no184z) were loosened from the univation xf system.Neither component showed cement adhesion.Thus, these had to be explanted and replaced with a bicondylar vega.The patient underwent a revision procedure on an unknown date.The complaint device has not been returned to the manufacturer for evaluation.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00394 (400511822 + no184z) 9610612-2021-00395 (400511821 + no161z) involved components: nl492 - univation f meniscal comp.T5 rm/lm 10mm - unknown.
Event or Problem Description
The adverse event is filed under aag reference (b)(4) ((b)(4)).
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: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 4(5) 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.

• Brand Name: AS UNIVATION XF TIBIA CEMENTED T6 RM
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11845293
• Report Number: 9610612-2021-00395
• Device Sequence Number: 11898595
• Product Code: HRY
• UDI-Device Identifier: 04046964053726
• UDI-Public: 4046964053726
• 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: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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: NO161Z
• Device Catalogue Number: NO161Z
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/16/2021
• 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: NO184Z - UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention