MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF TIBIA CEMENTED T3 RM; KNEE ENDOPROSTHETICS

Model Number NO158Z

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

Patient Problem Failure of Implant (1924)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Investigation on going.Additional results 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 on the right side is loosening after 1 year and 3 months.A revision surgery was 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: (b)(4).

Manufacturer Narrative

Investigation results: visual investigation: the device was returned for investigation.The femoral-as well as the tibial component show no device failure or serious damage.The tibial component show bone cement residues on the whole intended area/ coated surface.This indicates that a loosening between the bone and bone cement has taken place.The bone cement residues from the tibial component shows a partly good bone anchorage (cement interlock into the bone trabeculae) has taken place.The femur component show only little/partially bone cement residues.The meniscal components show several little imprints and scratches, which probably resulting from third body wear (bone chips and/or bone cement residues).Two of the provided x-ray figures show a bony loosening of the tibial component batch history review: already provided.Conclusion and measures: based on the investigation results a clear conclusion cannot be drawn.There are no hints for a material defect.There are several root causes for an implant loosening out of the bone bed: a potential low - grade infect.A bone cement allergy could also be a root cause for bony loosening of the cement.

Event Description

Associated medwatch-reports: 9610612-2020-00674 (400487314 no183z), 9610612-2020-00675 (400487316 no158z).

Manufacturer Narrative

Investigation results: the device was not returned.Therefore a investigation of the device itself is not possible.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 no similar complaints against the same lot number with this error pattern.Conclusion and measures: based on the provided information and without a product for investigation, a clear conclusion can not be drawn.A product safety case and further investigations were initiated.

Event Description

Associated medwatch-reports: 9610612-2020-00674 ((b)(4) no183z), 9610612-2020-00675 ((b)(4) no158z).

• Brand Name: AS UNIVATION XF TIBIA CEMENTED T3 RM
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10844118
• MDR Text Key: 216387220
• Report Number: 9610612-2020-00675
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2020

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
• Device Operator: Health Professional
• Device Model Number: NO158Z
• Device Catalogue Number: NO158Z
• Device Lot Number: 52423446
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 10/29/2020; 10/29/2020
• Supplement Dates FDA Received: 12/01/2020; 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NL472-52452175; NL472-52452175; NL472-52452175; NL472-52452175; NL472-52452175
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR