MAUDE Adverse Event Report: AESCULAP AG ALL POLY TIBIA COLUMBUS CR DD T1 10MM KNEE ENDOPROSTHETICS

Model Number NN1210

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Implant Pain (4561)

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 nn1210-all poly tibia columbus cr dd t1 10mm. According to the complainant, the patient underwent a right knee revision surgery after the primary surgery due to pain and instability. The 10 mm poly insert was replaced with a 16 mm insert. At the end of the revision procedure, it was noted that the patient was stable and had suitable flexion and extension. An additional intervention was required. Also, the product was discarded on site and the operative report is not available. The adverse event / malfunction is filed under aag reference (b)(4).

• Brand Name: ALL POLY TIBIA COLUMBUS CR DD T1 10MM
• 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: 11281230
• MDR Text Key: 230432165
• Report Number: 9610612-2021-00048
• Device Sequence Number: 1
• Product Code: JHW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: NN1210
• Device Catalogue Number: NN1210
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2021
• 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 Treatment Data

Date Received: 02/04/2021 Patient Sequence Number: 1