MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS BIOLOX PROSTHESIS HEAD 12/14 32MM S; HIP ENDOPROSTHESES

Model Number NK560

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Missing Value Reason (3192)

Event Date 04/03/2016

Event Type  Injury  

Event Description

Country of complaint: (b)(6).A 12y 6m po ceramic ball head fracture.The doctor through rx identified the ceramic head implanted in the patient in 2003 was broken in several pieces.Revision surgery required.Precise date of the implantation: not informed, it was only informed that the patient had 12 and a half years of implantation; precise date of revision surgery: not informed; x-rays after first surgery and after breakage; the physician that reported the event said that did not happen any incident with the patient before the breakage.

• Brand Name: BIOLOX PROSTHESIS HEAD 12/14 32MM S
• Type of Device: HIP ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5634293
• MDR Text Key: 44499096
• Report Number: 3005673311-2016-00077
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K060918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2016

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?: No
• Device Operator: No Information
• Device Model Number: NK560
• Device Catalogue Number: NK560
• Device Lot Number: 51158489
• Distributor Facility Aware Date: 04/26/2016
• Initial Date Manufacturer Received: 04/08/2016
• Initial Date FDA Received: 05/05/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 90