MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-24 for COLUMBUS UCR TIBIAL PLATEAU CEMENTED T2+ NN674K manufactured by Aesculap Ag & Co. Kg.
[22691165]
Reported device and involved components nn260p and nn620 are not marketed in the u. S. However, similar devices are. Additionally, component involved nn036k is marketed in the u. S. 510(k): k022672. Manufacturing site evaluation: component nn674k was received for evaluation. The tibia plateau displayed no indications of the adherence of bone cement. Component nn036k was received for evaluation. This component is plasmapore-coated. There is no indication of osseointegration on the implant. The lack of bone cement / osseointegration on the received implants may have been removed during explantation or during cleaning of implants prior to return. Quality and production documents were reviewed for reported batch numbers, there were no indications of a material or manufacturing defect. Results: it appears that the bone cement did not adhere with the bone and the implant as intended. This may result in a loosening. There are many factors that may lead to nonexisting osseointegration or non-adherence of bone and bone cement, this includes: incorrect application of the bone cement; pollution of the surface of the implant (blood, water, etc); allergic reaction of the bone cement or implant; use of no or too little bone cement; or, recovery disorder- damaged bone may be decomposed and removed from the implant retroactively. In cases of early loosening of an implant it is possible that the loosening occurred due to sepsis. Component nn260p was received and determined to be according to specification and unrelated to the reported incident. Component nn620 was received and determined to be according to specification and unrelated to the reported incident. Based on the information received and the evaluation of all components root cause for the loosening of the implant can not be determined. There were no material or manufacturing defects found in any of the components. Corrective and preventive action: not applicable.
Patient Sequence No: 1, Text Type: N, H10
[22691166]
Country of complaint: (b)(6). Post operative loosening of tibial component. Patient experienced pain in support, located on anteromedial tibia face. Probable loosening of the tibial component. Fibrous interposition 1cm on the inner posterior tibial prosthesis, brittle subchondral bone on external tibial prosthesis, external tibial implant and external neck. Related components: nn260p / plug f/tibial plateau. Batch # 51868498. Nn036k / columbus cr femoral comp. Plasmapore f6r. Batch # 51796372. Nn620 / columbus ucr gliding surface t2/2+ 10mm. Batch # 51839005.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005673311-2015-00079 |
| MDR Report Key | 4950371 |
| Date Received | 2015-07-24 |
| Date of Report | 2015-07-23 |
| Date Mfgr Received | 2014-01-21 |
| Device Manufacturer Date | 2012-01-01 |
| Date Added to Maude | 2015-07-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG&CO KG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COLUMBUS UCR TIBIAL PLATEAU CEMENTED T2+ |
| Generic Name | KNEE ENDOPROSTHESES |
| Product Code | JHW |
| Date Received | 2015-07-24 |
| Model Number | NN674K |
| Catalog Number | NN674K |
| Lot Number | 51791848 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG & CO. KG |
| Manufacturer Address | TUTTLINGEN, DE 78532 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-24 |