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

Model Number AE-QAS-K521-99

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Swelling (2091); Ambulation Difficulties (2544)

Event Date 01/06/2019

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 enduro knee system.Specifically, it was reported that as a result of having the product implanted the patient has experience, knee pain, difficulties in walking and swelling.The primary surgery occurred on (b)(6) 2017, and the revision surgery occurred on (b)(6) 2019.Additional information was not available.A revision was performed.The adverse event is filed under reference (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: internal notification number: (b)(4).Device reference code ae-qas-k521-99, device name collect.No.Qas knee, impl.Misc./unknown, serial number n/a, batch number unknown, udi device identifier unknown, udi production identifier unknown, basic udi-di n/a, unit of use udi-di unknown, manufacturing date unknown.No product at hand.Therefore a failure description at the device is not possible.There are no pictures available.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Explanation and rationale: in the light of the little information received and due the circumstance that we did not received the complained devices it is not possible to determine a root cause for the mentioned failure.Conclusion and root cause: due to the current deviation and according the rationale, it is not possible to determine a root cause for the mentioned failure.Corrective action: this case concerning implant loosening (vega loosening) was assigned a product safety case (psc).

Event Description

No updates.

• Brand Name: COLLECT.NO.QAS KNEE IMPL.MISC./UNKNOWN
• Type of Device: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10240400
• MDR Text Key: 198093264
• Report Number: 2916714-2020-00216
• 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
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• 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: 09/04/2020
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention