MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF TIBIA CEMENTED T5 LM; KNEE ENDOPROSTHETICS

Model Number NO166Z

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

Patient Problem Failure of Implant (1924)

Event Date 04/26/2022

Event Type  Injury  

Event Description

It was reported that there was an issue with the product no166z - as univation xf tibia cemented t5 lm.According to the complaint description, the implant started loosening post operative on the left side.A revision surgery was necessary.Additional information was not provided nor available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2023-00173 ((b)(4) + no188z).Involved components: nl474 - univation f meniscal comp.T5 rm/lm 7mm - lot 52431250.

Manufacturer Narrative

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

Event Description

Associated medwatch-reports: 9610612-2023-00172 ((b)(4) + no166z).9610612-2023-00173 ((b)(4)+ no188z).Involved components: nl474 - univation f meniscal comp.T5 rm/lm 7mm - lot 52431250.

Manufacturer Narrative

Investigation results: no product at hand, therefore an investigation of the products is not possible.Device history review: the device quality and manufacturing history records have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are 0 similar complaints against the same lot number.The current failure rate is within the risk analysis and therefore acceptable.Conclusion and preventive 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.There are several and often complex root causes for an implant loosening.Possibly due to septic conditions or, for example, to incorrect loading, too early or too high loading, which may also have occurred long before the onset of loosening, suboptimal positioning (due to the patient), inappropriate choice of implant, inappropriate surgical procedure or inappropriate cementing technique, and many others.Based upon the investigation results, a capa is not necessary.

Manufacturer Narrative

Additional information: d9 - product return date.H3 - yes, evaluation.H6 - codes updated.Investigation results: visual examination: the femoral-as well as the tibial component show no device failure or serious damage.The provided tibial component shows firmly fixed bone cement mantle on almost the whole intended area/ coated surface.This indicates that a loosening between the bone and bone cement has taken place.The bone cement mantle from the tibial component shows that a good bone anchorage (cement interlock into the bone trabeculae) has taken place.The femoral component shows only a bone cement mantle fragment on the intended area with only less bone anchorage.Furthermore there are visible marks on the implant surface area which is intended for the bone cement.The bone cement mantle fragment is no more fixed on the surface of the femoral component.The gliding surface shows little imprints and scratches, which probably resulting from third body wear (bone chips and/or bone cement residues).Device history review: the device quality and manufacturing history records have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are 0 similar complaints against the same lot number.According to manufacturer's reporting evaluation in accordance with 21 cfr 803, section 803.3, this event is considered reportable for the following reason: - serious injury (report not later than 30 days).The assessment for the reportability of this adverse event is based on patient harm, revison surgery.Conclusion and preventive measures: on the basis of the current information, a clear conclusion for the implant loosening cannot be drawn.The provided x-ray figures give also no clear hints regarding the definitive root cause of the loosening.X-rays in direct comparison showed that the tibial component had sunk over time.This fact was also described in a medical letter dated 2022-05-03.The device history records have been checked and no abnormalities could be observed.There are no hints for a device problem.Based upon the investigation results, a capa is not necessary.

• Brand Name: AS UNIVATION XF TIBIA CEMENTED T5 LM
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 17299606
• MDR Text Key: 318925689
• Report Number: 9610612-2023-00172
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NO166Z
• Device Catalogue Number: NO166Z
• Device Lot Number: 52502730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NL474 - LOT 52431250; NL474 - LOT 52431250
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male