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

Model Number AE-QAS-K521-99

Device Problems Unstable (1667); Patient-Device Incompatibility (2682)

Patient Problems Edema (1820); Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Weight Changes (2607)

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 patient was initially implanted with enduro components on (b)(6) 2019.It was noted that the patient experienced instability of knee joint, knee pain, infection-inflammation, lymphedema, nickel allergy, and sudden unexplained weight loss.There later was a failed total knee and revision on (b)(6) 2020.A revision surgery was necessary.The implant that was revised was the aesculap enduro femur.Additional information was requested.Operative records were not provided.The adverse event is filed under xc (b)(4).

Manufacturer Narrative

Section d: leading material updated.

Event Description

No update provided.

Manufacturer Narrative

General information: we received a complaint regarding enduro components.This is one of 12 cases regarding "problems with enduro components." up to now, there are no devices available for investigation.Consequences for the patient: post-operative medical intervention was necessary.Revision surgery.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.Corrective action: product safety case was created.

Event Description

No update provided.

• 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: 9953907
• MDR Text Key: 187800615
• Report Number: 2916714-2020-00079
• 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: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• 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: 06/10/2020
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention