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

Model Number NO165Z

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

Patient Problem Failure of Implant (1924)

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 loosening after 1years and 3 month.A revision surgery was on (b)(6) 2019 necessary.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: 9610612-2020-00668 (b)(4).(b)(4).Involved components univation f meniscal (b)(4).

Event Description

The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00668 ((b)(4) no188z), 9610612-2020-00669 ((b)(4) no165z).Involved components: univation f meniscal (b)(4).

Manufacturer Narrative

Investigation results: visual investigation: the components were examined microscopically.Little bone cement residues were visible.The coated surface shows little visible signs of abrasion.The origin of this traces are unknown.Possibly the traces were created during the explantation and are not related to the implant loosening.The provided x-ray figures give no hints regarding the root cause of the implant loosening.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are 2 similar complaints against the same lot number: 52328889 (all registered as involved component).Conclusion an measures: on the basis of the current information, a clear conclusion cannot be drawn.The device history records have been checked and no abnormalities could be observed.There are no hints for a material/device problem.Further investigations unter (b)(4) are on-going to define a definite root cause for the failure.

Manufacturer Narrative

Investigation results: after further examination, it is not yet possible to determine the cause of the implant loosening.A material defect can be ruled out.Loosening of an implant can have many causes.For example, the cementing technique or also patient-related.

Event Description

Associated medwatch-reports: 9610612-2020-00668 ((b)(4) no188z), 9610612-2020-00669 ((b)(4) no165z) involved components: univation f meniscal -52328889.

• Brand Name: AS UNIVATION XF TIBIA CEMENTED T4 LM
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10843799
• MDR Text Key: 216359102
• Report Number: 9610612-2020-00669
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2020

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: NO165Z
• Device Catalogue Number: NO165Z
• Device Lot Number: 52336161
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NL473-52328889; NL473-52328889
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR