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

Model Number NO157Z

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with no157z - as univation xf tibia cemented t2 rm.According to the complaint description, a revision operation took place due to loosening of the implant.A revision surgery was necessary.Additional information was not available.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Involved components nl471 - univation f meniscal comp.T2 rm/lm 7mm - batch unknown.

Manufacturer Narrative

Investigation results: visual investigation: the femoral-as well as the tibial component show no device failure or serious damage.The components were examined visually and microscopically.The provided femoral component show bone cement residues on almost the whole intended area/ coated surface.This indicates that a loosening between the bone and bone cement has taken place.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 2 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 prbability 2(5) of occurrence) 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.Based upon the investigations results a capa is not necessary.

• Brand Name: AS UNIVATION XF TIBIA CEMENTED T2 RM
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11542925
• MDR Text Key: 251229512
• Report Number: 9610612-2021-00288
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NO157Z
• Device Catalogue Number: NO157Z
• Device Lot Number: 52512495
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention