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

Model Number NO166K

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

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 the product no166k - univation xf tibia cemented t5 lm.According to the complaint description, the implant caused a large cyst femoral formation and tibial loosening.This event occured after 5 years and 7 months from the implantation date.A revision surgery was necessary.Additional information was not provided nor available.Additional patient information is not available.The adverse event is filed under aag reference 100033284 (400611362).Associated medwatch-reports: 9610612-2023-00188 ((b)(6) + no166k), 9610612-2023-00162 ((b)(6) + no188k).Involved components: nl474 - univation f meniscal comp.T5 rm/lm 7mm - lot 52331268.

Manufacturer Narrative

Additional information: h3 - evaluation.H6 - codes updated.Investigation result: in the delivered condition the tibial component shows a firmly fixed cement mantle on the intended area/coated surface.These bone cement residues show bone anchorage (cement interlock into the bone trabeculae).Furthermore one area of the surface shows chisel marks which may have resulted from the explantation procedure.The provided femoral component shows only less bone cement residues on the intended area/ coated surface.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).One side of the gliding surface shows massive material abrasion and grinding marks.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.Explanation and rationale: 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 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.The provided x-ray figures give no clear hints regarding the root cause for the implant loosening.Based upon the investigation results, a capa is not necessary.

Event Description

Associated medwatch-reports: 9610612-2023-00188 ((b)(4) + no166k).9610612-2023-00162 ((b)(4) + no188k).Involved components: nl474 - univation f meniscal comp.T5 rm/lm 7mm - lot 52331268.

• Brand Name: 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: 17495345
• MDR Text Key: 320755845
• Report Number: 9610612-2023-00188
• 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: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NO166K
• Device Catalogue Number: NO166K
• Device Lot Number: 52309773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2017
• 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 52331268; NL474 - LOT 52331268
• Patient Outcome(s): Required Intervention