MAUDE Adverse Event Report: AESCULAP AG COLUMBUS CR DD GLID.SURFACE T2/2+ 14MM; GLIDING SURFACES/PATELLAS COLUMBUS

Model Number NN222

Device Problem Delamination (2904)

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

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

(b)(6).It is reported that both the patellae implant and the insert was removed.The patellae is very worn but the concern in the breakage, the insert has wear but also appears to have delamination of the material.The primary surgery was performed on (b)(6) 2008.

Manufacturer Narrative

Investigation: the components have been examined visually and microscopically with a keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera.The case was discussed with a specialist from product management.The patella x ray marker of the nn481 is broken.Furthermore, the patella implant shows strong wear marks, one sided friction marks, therefore we assume that the patella was not in the intended central position.Due to this damage, the patella x ray marker broke in to two pieces.Three anchorage pins are also broken off.The nn222 also shows visible wear marks and delaminations on the gliding surface.We assume that these wear marks (third body wear marks) were caused by the broken piece of the ring which entered the sliding surface between the inlay and the femur component.According to the product management the condition of the nn222 is not unusual after nearly 10 years implanted.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers.The device history file has been checked and found to be according to our spcification valid at the time of production.No similar incidents have been filed with products from these batches.Conclusion and root cause: based on the information available, it is not possible to determine a possible root cause of the failure.We assume that the failure is not product related.Rational: there are no hints of a material problem.According to the quality standard and dhr files, a material defect and production error can be excluded.Afterwards it is not possible to determine why/since when the patella component was not in the intended central position.According to the product management, the condition of the explanted nn222, is not unusual after nearly 10 years of implanted.No capa is necessary.Corrected data: added adverse event to completely catagorize event.Changed to "required intervention to prevent permanent impairment/damage." corrected expalnt date.Added information.Added information.Corrected type of reportable event.

Event Description

This event is linked with mdr 9610612-2018-00399.

• Brand Name: COLUMBUS CR DD GLID.SURFACE T2/2+ 14MM
• Type of Device: GLIDING SURFACES/PATELLAS COLUMBUS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7434528
• MDR Text Key: 105677913
• Report Number: 9610612-2018-00188
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K023788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2011
• Device Model Number: NN222
• Device Catalogue Number: NN222
• Device Lot Number: 51380983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Distributor Facility Aware Date: 04/10/2018
• Device Age: 11 YR
• Date Manufacturer Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention