MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS BIOLOX PROSTHESIS HEAD 12/14 28MM S; IMPLANTS STANDARD PROSTHESES HEADS

Model Number NK460

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problem Hip Fracture (2349)

Event Date 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

(b)(6).After spontaneous movement a crackling sound in the right side of hip was noticed by the patient.Fracture of ceramic head could be detected by x-ray.Revision surgery with removing the broken head and changing the inlay was on (b)(6) 2018.Primary surgery was on (b)(6) 2001 at (b)(6).Components in use listed as concomitant devices are: nk460 / biolox prosthesis head 12/14 28mm s, nh054t / plasmacup sc size 54mm, nh093 / sc/msc ceramics insert 28mm 52/54 sym., nk662t / antega plasmapore 12/14 size 12mm right.

Manufacturer Narrative

Investigation: the ceramic ball head cannot be completely reconstructed from the delivered fragments.The density of the fragments was tested and found to be within specification.There are metal transfer patters on the surface of the ball head.Batch history review: the manufacturing history records have been checked and found to be according to specification, valid at the time of production.Conclusion and root cause: on the basis of the investigation, a product related failure can be excluded.There are no indications of a material defect or manufacturing error.The failure is most probably patient (overload) or user (implantation situation) related.No capa is necessary.

• Brand Name: BIOLOX PROSTHESIS HEAD 12/14 28MM S
• Type of Device: IMPLANTS STANDARD PROSTHESES HEADS
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7316863
• MDR Text Key: 101718958
• Report Number: 9610612-2018-00081
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NK460
• Device Catalogue Number: NK460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Distributor Facility Aware Date: 02/15/2018
• Initial Date Manufacturer Received: 02/09/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 02/09/2018
• Supplement Dates FDA Received: 04/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NH054T / PLASMACUP SC SIZE 54MM; NH093 / SC/MSC CERAMICS INSERT 28MM 52/54 SYM.; NK460 / BIOLOX PROSTHESIS HEAD 12/14 28MM S; NK662T / ANTEGA PLASMAPORE 12/14 SIZE 12MM RIGHT
• Patient Outcome(s): Other
• Patient Age: 65 YR