MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS BIOLOX PROSTHESIS HEAD 12/14 28MM S; HIP ENDOPROSTHESES

Model Number NK460

Device Problem Fracture (1260)

Patient Problem Missing Value Reason (3192)

Event Date 05/01/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: on-going.

Event Description

Country of complaint: (b)(6).Twelve year post operative fracture of ceramic head.Primary surgery: (b)(6) 2004.Revision surgery: (b)(6) 2016.Components involved: nk460 / biolox prosthesis head 12/14 28mm s / batch number 51217065.Nh091 / sc/msc ceramics insert 28mm 44/46 sym./ batch number 51210983 (not a u.S.Marketed device).Nh046t / plasmacup sc size 46mm / batch number 51224806 (not a u.S.Marketed device).Nk712t / bicontact sd plasmapore 12/14 size 12mm / batch number 51202282 (not a u.S.Marketed device).

Manufacturer Narrative

The density of the ball head was analysed and found to be according to the specifications valid at time of production.The microstructures as obtained from the quality documents of both parts accomplish the requirements as specified at the time of production, too.There are no indications of any pre-existing material defect secondary metal transfer patterns can be found on the fragment of the insert and on the ball head as a result of contact with metal parts after the primary fracture event.Primary regular metal transfer can be found with varying intensity on the ball head.A primary fracture surface and the region of the fracture origin can not be found on the fragment of the insert due to secondary damages.Primary regular metal transfer can be found with varying intensity on the insert.Metal carry on the end face of the insert indicates impingement between shaft and insert.However, it can not be clearly established whether this impingement occurred before or after the primary breaking event of the ball head.On the polished surface of both parts areas with stripe wear can be found.This indicates an edge-loading situation or recurring subluxations.The evaluation of the ceramic components is based on the investigation of the manufacturer of the broken ceramic insert and the ceramic head.

• Brand Name: BIOLOX PROSTHESIS HEAD 12/14 28MM S
• Type of Device: HIP ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5535525
• MDR Text Key: 41469805
• Report Number: 3005673311-2016-00044
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 03/30/2016

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 Expiration Date: 07/31/2014
• Device Model Number: NK460
• Device Catalogue Number: NK460
• Device Lot Number: 51217065
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/18/2016
• Initial Date Manufacturer Received: 03/07/2016
• Initial Date FDA Received: 03/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2004
• 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
• Patient Age: 78 YR
• Patient Weight: 74