MAUDE Adverse Event Report: AESCULAP AG & CO. KG ENDURO TIBIAL COMP. OFFSET CEMENTED T2; KNEE PROSTHESIS

Model Number NB012K

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).A revision surgery was carried out due to another reason (currently unk).It was seen intraoperatively that the rotation axis did not move.

Manufacturer Narrative

Eval on-going.

• Brand Name: ENDURO TIBIAL COMP. OFFSET CEMENTED T2
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): AESCULAP AG & CO. KG; tuttlingen 7853 2; GM 78532
• Manufacturer (Section G): AESCULAP AG & CO KG; po box 40; tuttlingen 7850 1; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe dr; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 4417698
• MDR Text Key: 5275906
• Report Number: 3005673311-2015-00002
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2015
• Device Model Number: NB012K
• Device Catalogue Number: NB012K
• Device Lot Number: 51711103
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/11/2014
• Was Device Evaluated by Manufacturer?: No
• 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