MAUDE Adverse Event Report: AESCULAP AG AS COLUMBUS CR/PS TIB.PLAT.CEMENTED T2; KNEE ENDOPROSTHESES

Model Number	NN073Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information or investigation results become available, a supplement will be provided.
Event or Problem Description
It was reported that there was an issue with the product columbus tibial plateau.The original surgery was in (b)(6) 2017.The patient had complained of "popping" and knee pain.The surgeon recommended a revision and during the procedure, noted that the primary tibia was loose and there was no cement adherent to the implant.The implant was replaced with stemmed and augmented tibia in (b)(6) 2020.The patient outcome was good postoperatively at 1 week.The adverse event is filed under reference (b)(4).Concomitant products: palacos r cement, columbus gliding surface nn423, lot 52034639, columbus narrow femur nn899z, lot 52275242, tibial obturator nn261a, lot 52294345, patella 3 pegs nx042, lot 52294458.
Additional Manufacturer Narrative
Associated medwatches: (this report), 2916714-2020-00730, 2916714-2020-00731, 2916714-2020-00732, 2916714-2020-00733.Investigation results: visual investigation: the surface intended for the bone cement shows no conspicuous damage or abnormality.There are only smallest bone cement residues on the tibial component in the actual situation.There are no damages or other abnormalities regarding the surface of the implant.The visible discoloration of the tibial component surface is a result of oxidation and does not affect the material properties in any way.The provided x-ray figures give no definitive hints for the root cause of the implant loosening.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.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.Based upon the investigations results a capa is not necessary.
Event or Problem Description
No updates.
Additional Manufacturer Narrative
Additional information - linked mdrs/components: 2916714-2020-00720 (this report), 2916714-2020-00730, 2916714-2020-00731, 2916714-2020-00732, 2916714-2020-00733.
Event or Problem Description
No updates.

• Brand Name: AS COLUMBUS CR/PS TIB.PLAT.CEMENTED T2
• Common Device Name: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11078200
• Report Number: 2916714-2020-00720
• Device Sequence Number: 19723020
• Product Code: JWH
• UDI-Device Identifier: 04046963119034
• UDI-Public: 4046963119034
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2021
• Report Date (Section F): 12/28/2020

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: NN073Z
• Device Catalogue Number: NN073Z
• Device Lot Number: 52295933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/08/2020
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 01/05/2021; 03/24/2021
• 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: 63 YR
• Date Report Sent to FDA: 12/28/2020