MAUDE Adverse Event Report: AESCULAP AG COLLECT.NO.QAS KNEE IMPL.MISC./UNKNOWN; KNEE ENDOPROSTHETICS

Model Number AE-QAS-K521-99

Device Problems Material Fragmentation (1261); Unstable (1667); Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924); Pain (1994)

Event Date 03/19/2020

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 as enduro femoral component.The pre-operative diagnosis in 2017 was multi-directional instability following the primary knee with a nickel allergy of the left knee and left knee pain.The patient was initially implanted with enduro components on (b)(6) 2017.All components were cemented one-on-one with tobramycin placement of stimulan pellets with 240mg of tobramycin follow by 100mg of vancomycin per mixture.There later was a failed left total knee, revision secondary to wear and debris of left knee on (b)(6) 2020, and there had been increased pain noted prior to surgery.A revision surgery was necessary.The implant that was revised was the aesculap enduro femur.A porex component from link with niobium was used instead.Additional information was requested.The adverse event is filed under xc (b)(4).

Event Description

No update.

Manufacturer Narrative

Section d: leading material updated.

Event Description

No update.

Manufacturer Narrative

Investigation: no product at hand, therefore an investigation at the devices is not possible.Batch history review: a review of the device quality and manufacturing history records is not possible because the material number as well as the batch number is unknown.Conclusion and root cause: based on the information available it is not possible to determine a definitive root cause for the failure at that time.Rationale: on the basis of the current information and without a product for investigation, a clear conclusion/root cause for the implant loosening can not be drawn.At that time it is not possible to verify if the black staining/debris is responsible for the implant loosening.There are many potential sources regarding to implant loosening: modification/ change in the surgical technique.Cement technique; patient fall; patient allergy/infection.Corrective action: product safety case was created.

• Brand Name: COLLECT.NO.QAS KNEE IMPL.MISC./UNKNOWN
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9938860
• MDR Text Key: 187399095
• Report Number: 2916714-2020-00086
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AE-QAS-K521-99
• Device Catalogue Number: AE-QAS-K521-99
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/17/2020
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR