MAUDE Adverse Event Report: AESCULAP AG BIOLOX PROSTHESIS HEAD 12/14 28MM S; HIP ENDOPROSTHESES - HEADS

Model Number NK460

Device Problems Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Fall (1848); Patient Problem/Medical Problem (2688)

Event Date 08/14/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.

Event Description

It was reported that there was an issue with product nk460.Background: post-operative course of the patient had been good since the initial surgery until last year (not known exactly when).The patient consulted the hospital for unusual noise audible from the hip implant last year, and the surgeon advised the patient to avoid much load on the implant in the daily routine.However, the patient fell down in 14th august this year.Ct scan image revealed sign of breakage of the ceramic implant.Remedial action for the patient.Intra-operative observation of the prostheses revealed fracture of both the ceramic insert and the femoral head.The ceramic insert and the femoral head were replaced with brand new ones.A revision surgery was necessary.An additional medical intervention was necessary.The adverse event filed under aag reference (b)(4).Additional information was not provided.The components involved (excluding ceramic insert and femoral head) - ceramic insert not sold in usa: nh150t : plasma cup msc 50 mm (51235601), nk727t : bicontact stem 17 mm 12/14 (51090020n), na766t : screw 6.5 x 16 mm (2 pcs) (51204594, 51215643), na774t : screw 6.5 x 24 mm (1pcs) (51213330), na778t : screw 6.5 x 28 mm (1 pcs) (51205240), na794t: screw 6.5 x 44 mm (1 pcs) (51141682).

• Brand Name: BIOLOX PROSTHESIS HEAD 12/14 28MM S
• Type of Device: HIP ENDOPROSTHESES - HEADS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9100273
• MDR Text Key: 161084715
• Report Number: 9610612-2019-00629
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 09/19/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2014
• Device Model Number: NK460
• Device Catalogue Number: NK460
• Device Lot Number: 51229383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2004
• 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): Required Intervention
• Patient Age: 82 YR