MAUDE Adverse Event Report: AESCULAP AG AND CO. KG BILOX PROSTHESIS HEAD 12/14 28MM L; HIP ENDOPROTHESIS.

Model Number NK462

Device Problem Battery charger, defective (1054)

Patient Problem No Information (3190)

Event Date 04/08/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Spontaneous post operative insert breaking on the right side.Radiologically visible; crushed ceramic head.

Manufacturer Narrative

Mfg site eval: awaiting product return.Add'l 510(k): k081973 and k083495.

• Brand Name: BILOX PROSTHESIS HEAD 12/14 28MM L
• Type of Device: HIP ENDOPROTHESIS.
• Manufacturer (Section D): AESCULAP AG AND CO. KG; tuttlingen, de
• Manufacturer (Section G): AESCULAP AG AND CO KG; po box 40; tuttlingen 7850 1; GM 78501
• Manufacturer Contact: michelle link ; 615 lambert pointe dr; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 3877267
• MDR Text Key: 4512589
• Report Number: 3005673311-2014-00053
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: K060918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NK462
• Device Catalogue Number: NK462
• Device Lot Number: 512504258
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2004
• 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