MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS COLLECT.NO.QAS KNEE IMPLANTS COLUMBUS; KNEE ENDOPROSTHETICS

Model Number AE-QAS-K521-53

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2010

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Device not return.

Event Description

Country of complaint: usa.Patient #4: patient had a size 4 columbus femur and size 2 columbus tibia with 14 mm poly that has been dislocating.Patient needed a custom poly to correct dislocating.Components in use listed as concomitant devices are: ae-qas-k521-53 / collect.No.Qas knee implants columbus, ae-qas-k521-53 / collect.No.Qas knee implants columbus, ae-qas-k521-53 / collect.No.Qas knee implants columbus.

Manufacturer Narrative

Investigation: no product is at hand.Conclusion and root cause: no product available and therefore an analysis is not possible.No capa is necessary.

• Brand Name: COLLECT.NO.QAS KNEE IMPLANTS COLUMBUS
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 7049283
• MDR Text Key: 93199393
• Report Number: 9610612-2017-00578
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AE-QAS-K521-53
• Device Catalogue Number: AE-QAS-K521-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/16/2017
• Initial Date Manufacturer Received: 10/29/2017
• Initial Date FDA Received: 11/21/2017
• Supplement Dates Manufacturer Received: 10/29/2017
• Supplement Dates FDA Received: 03/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention