MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF TIBIA CEMENTED T2 LM; KNEE ENDOPROSTHETICS

Model Number NO163Z

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

Patient Problem Insufficient Information (4580)

Event Date 04/15/2019

Event Type  Injury  

Manufacturer Narrative

Investigation on going.Additional information will be submitted in a supplemental report.

Event Description

It was reported that there was an issue with product as univation xf tibia.According to the complaint description it was reported that the implant.Right side loosening after 3months and 18 days.A revision surgery has not yet been performed.Both knee were implanted.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00670 (400487303 no181z).9610612-2020-00671 (400487304 no157z).9610612-2020-00672 (400487307 no186z).(400487308 no163z).Involved components.Univation f meniscal comp.T2 rm/lm 7mm - 52410754.Univation f meniscal comp.T2 rm/lm 7mm - 52323238.

Manufacturer Narrative

Left side includes following devices: no186z - as univation xf femur cemented f2 lm; no163z - as univation xf tibia cemented t2 lm; nl471 - univation f meniscal comp.T2 rm/lm 7mm.Right side includes following devices: no181z - as univation xf femur cemented f2 rm; no157z - as univation xf tibia cemented t2 rm; nl471 - univation f meniscal comp.T2 rm/lm 7mm.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 there are 2 similar complaints against the same lot number 52416316.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 a capa is not necessary.Further investigations were initiated under a product safety case (psc).

Event Description

Associated medwatch-reports: 9610612-2020-00670 (400487303 no181z); 9610612-2020-00671 (400487304 no157z);; 9610612-2020-00672 (400487307 no186z); 9610612-2020-00673 (400487308 no163z).Involved components univation f meniscal comp.T2 rm/lm 7mm - 52410754; univation f meniscal comp.T2 rm/lm 7mm - 52323238.

• Brand Name: AS UNIVATION XF TIBIA CEMENTED T2 LM
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10843927
• MDR Text Key: 217983037
• Report Number: 9610612-2020-00673
• Device Sequence Number: 1
• Product Code: HRY
• 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
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NO163Z
• Device Catalogue Number: NO163Z
• Device Lot Number: 52220118
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NL471-52323238; NL471-52323238; NL471-52410754; NL471-52410754
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 52 YR