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

Model Number	NN1210
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information or investigation results become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that there was an issue with poly tibia columbus 10mm.According to the complainant, the patient underwent a right knee revision surgery sometime after the primary surgery due to pain and instability.The 10 mm poly insert was replaced with a 16 mm insert.The replacement was performed on an unspecified date.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 was not available.The adverse event / malfunction is filed under (b)(4).
Additional Manufacturer Narrative
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.
Event or Problem Description
No updates.

• Brand Name: ALL POLY TIBIA COLUMBUS CR DD T1 10MM
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11286737
• Report Number: 2916714-2021-00007
• Device Sequence Number: 4371642
• Product Code: JWH
• UDI-Device Identifier: 04046964449963
• UDI-Public: 4046964449963
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2021
• Report Date (Section F): 02/04/2021

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
• Operator of Device: 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 12/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Date Report Sent to FDA: 02/04/2021