MAUDE Adverse Event Report: AESCULAP AG VATION XF TIBIA CEMENTED T2 RM; KNEE ENDOPROSTHESES

Model Number NO157Z

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

Patient Problem Failure of Implant (1924)

Event Date 08/25/2022

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, the patient presented to hospital on (b)(6) 2022 due to persistent right knee pain.An arthroscopy was performed on (b)(6) 2022.Pathological report showed abrasion of the knee prosthesis.A revision surgery was necessary.Additional information was not provided.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: (9610612-2022-00398 - no181z) - (b)(4).Involved components: nl483 - univation f meniscal comp.T2 rm/lm 9mm - lot 52121429.

Manufacturer Narrative

Investigation results: visual investigation: the available explants are in an undamaged condition and show no serious abnormalities or deviations.In the delivered condition the femoral component shows a firmly fixed cement mantle fragment on the intended area/coated surface.These bone cement residues show bone anchorage (cement interlock into the bone trabeculae).The provided tibial component shows almost no bone cement residues on the intended area/ coated surface.The discolorations on the surface of the gliding surface of the femoral component is due to oxidation.Such changes in color have no effect on the function or properties of the coating.The gliding surface of the meniscal component shows visible scratches and imprints.These imprints are probably resulting from third body wear (bone chips and/or bone cement residues).Furthermore there are massive wear in the border area of the gliding surface.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 no 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 probability 4(5) of occurrence) according to din en iso 14971 is still acceptable.Explanation and rationale: 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.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.

Event Description

The adverse event is filed under aag reference (b)(4) ((b)(4)).Associated medwatch-reports: (9610612-2022-00398 - no181z) - (b)(4).Involved components: nl483 - univation f meniscal comp.T2 rm/lm 9mm - lot 52121429.

• Brand Name: VATION XF TIBIA CEMENTED T2 RM
• Type of Device: KNEE ENDOPROSTHESES
• 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: 16184186
• MDR Text Key: 307482898
• Report Number: 9610612-2022-00399
• 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
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• 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: 52198595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2005
• 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: NL483 - LOT 52121429.; NL483 - LOT 52121429.
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female