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

Model Number NO159Z

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap ag that an as univation xf tibia cemented t4 rm (part # no159z) 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: 9610612-2021-00235 (400505588 - no183z) involved components nl473 - univation f meniscal comp.T4 rm/lm 7mm - 52494281.

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.

Event 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.

• Brand Name: AS UNIVATION XF TIBIA CEMENTED T4 RM
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11598600
• MDR Text Key: 251227053
• Report Number: 9610612-2021-00226
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 04046964053702
• UDI-Public: 4046964053702
• Combination Product (y/n): N
• PMA/PMN Number: K131167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NO159Z
• Device Catalogue Number: NO159Z
• Device Lot Number: 52481601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NL473 - 52494281; NL473 - 52494281
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR