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).

Manufacturer Narrative

Updated h6: codes.Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.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.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• 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: Health Professional
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female