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

Model Number AE-QAS-K521-55

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 07/01/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap aag that an enduro ktep (part # unknown) was implanted in the left knee as part of a two-stage septic prosthesis change on (b)(6) 2013.According to the complainant, the patient experienced instability of the knee joint.Reportedly, there were no interim follow-up visits.Additionally, before the peracute deterioration, the knee had not been pain-free for some time.The current deterioration was also preceded by a fall.Radiological disconnection of the anchoring nut with uncoupling of the femoral component from the stem extension and subsequent instability was observed.The patient underwent a revision procedure on an unknown date.The complaint device has not been returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Although requested, additional information has not been made available.The adverse event / malfunction is filed under aag reference xc (b)(4); cc (b)(4).

• Brand Name: COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE
• 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: 12537235
• MDR Text Key: 273578802
• Report Number: 9610612-2021-00628
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/27/2021
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR