MAUDE Adverse Event Report: AESCULAP AG & CO. KG COLUMBUS UCR TIBIAL PLATEAU CEMENTED T2+; KNEE ENDOPROSTHESES

Model Number NN674K

Device Problem Osseointegration Problem (3003)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: COLUMBUS UCR TIBIAL PLATEAU CEMENTED T2+
• Type of Device: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG & CO. KG; tuttlingen, de 78532
• Manufacturer (Section G): AESCULAP AG&CO KG; po box 40; tuttlingen 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 4950371
• MDR Text Key: 22691165
• Report Number: 3005673311-2015-00079
• Device Sequence Number: 1
• Product Code: JHW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NARRATIVE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Model Number: NN674K
• Device Catalogue Number: NN674K
• Device Lot Number: 51791848
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2012
• 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): Other
• Patient Age: 72 YR