MAUDE Adverse Event Report: AESCULAP AG COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE; KNEE ENDOPROSTHESES

Model Number AE-QAS-K521-55

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported that there was an issue with a product from rotating hinge knee implant system (enduro).According to the complaint description, there was postoperative axis break.The patient experienced a fall around christmas-time.A revision is scheduled for (b)(6) 2024 (currently considered inoperable due to an ulcer).According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, revision.No further data was provided nor available.The adverse event is filed under aesculap ag reference no.(b)(4)).

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: b5 - updated leading material and involved components.D1&2 - leading material, classification, product code.D4 - material, batch, expiration date.D9 - product return.D10 - involved components.G4 - 510k.H3 - yes, evaluation.H4 - manufacture date.H6 - codes updated.Investigation results: visual inspection: the rotation axis has fractured below the taper.The taper of the rotation axis shows nearly no damage /material abrasion on the surface.The rotation axis locknut is no longer located/fixed on the thread of the rotation axis.The breakage surface of proximal fragment shows little signs of so-called arrest lines which indicate a fatigue fracture and secondary damages.The breakage surface of the distal component shows mainly secondary damages (shiny surface).This indicates that this surface rubbed against something other after the breakage.There are no hints for a material failure like foreign material inclusions or blow holes.The thread of the rotation axis as well as the thread of the rotation axis locknut shows no abnormal visible damages.The gliding surface of the meniscal component shows only little visible and noticeable scratches and imprints (wear marks) which were possibly caused by bone cement and/or bone chips.Furthermore there are little metal abrasions/chips on the gliding surface.The bearing for rotation axis shows outwardly nearly no visible scratches or imprints.The locking ring shows material deformation.Batch 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 no similar complaints against the same lot numbers.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, revision surgery.Conclusion/preventive measures: on the basis of the current information and as well as a result of the investigation, a definitive conclusion cannot be drawn.The device history records have been checked and no abnormalities could be observed.There is no indication for a material defect or manufacturing failure.The following can be mentioned as an informational note: it was noted that the patient is very overweight, and that the rotation axis fracture was preceded by a fall.Based on this information, it is obvious that the fracture occurred due to an overload situation.Based upon the investigation results, a capa is not required.

Event Description

Update: revision was performed.The material was updated to nr890m - enduro meniscal component f3 10mm.Involved components: nb016k/ enduro femoral component cemented f3l - lot 52419075 (internal ag ref.No.(b)(4)) nr400k/ nut f/femur extens.Stem all sizes neutr.- lot 52412900 (internal ag ref.No.(b)(4)) nb013k/ enduro tibial comp.Offset cemented t3 - lot 52414014 (internal ag ref.No.(b)(4)) nr293k/ femur extens.Stem 6° d18x77mm cemented - lot 52419503 (internal ag ref.No.(b)(4)) nr193k/ tibia offset stem d18x52mm cemented - lot 52350040 (internal ag ref.No.(b)(4)).

• Brand Name: COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE
• 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: 18768933
• MDR Text Key: 336179142
• Report Number: 9610612-2024-00035
• Device Sequence Number: 1
• Product Code: HRZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101815
• 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: 05/02/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AE-QAS-K521-55
• Device Catalogue Number: AE-QAS-K521-55
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2018
• 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: NB013K- LOT 52414014; NB016K - LOT 52419075; NR193K - LOT 52350040; NR293K - LOT 52419503; NR400K - LOT 52412900
• Patient Outcome(s): Required Intervention