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

Model Number NK460

Device Problem Fracture (1260)

Patient Problem Joint Disorder (2373)

Event Date 05/13/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with biolox prosthesis head.According to the customer it was reported that there was a fracture of the ceramic ball head.Initial surgery date: (b)(6) 2004.Revision surgery: (b)(6) 2020.Date of fracture: (b)(6) 2020.Sudden crackling in the hip with pain and limitation of the ability to walk.A revision surgery was necessary.Additional information has been requested but not yet received as of this report.The adverse event is filed under aag reference (b)(4).Involved components (aufführen in d11 + c2) nh092 - sc/msc ceramics insert 28mm 48/50 sym.- 51205555.Nh050t - plasmacup sc size 50mm - 51223662.Nk513t - bicontact s plasmapore 12/14 size 13mm - 51225247.

Manufacturer Narrative

Investigation results: the evaluation of the ceramic components is based on the investigation of the manufacturer of the ceramic components; data is filed under kiv 20 06 07.A combination of the used components is approved by aesculap ag.The failure is most probably patient or usage related.There is no indication for a material or manufacturing failure.According to the investigation results of the manufacturer: "the density of the ball head was analysed and found to be complying with the delivery specification for biolox®forte components.The microstructure as obtained from the quality documents of both parts fulfils the requirements as specified at the time of production.There are no indications of any pre-existing material defect.Secondary metal transfer patterns can be found on the fragments of the ball head and on the insert as a result of contact with metal parts after the fracture event or during the surgical procedures.The expected primary metal transfer can be found with varying intensity on the bore of the ball head.On one fragment the primary metal transfer cannot be evaluated due to secondary surface deterioration.Due to secondary damages and missing fragments the fracture origin cannot be identified on the fragments of the ball head.· primary metal transfer can be found with varying intensity and not equally distributed on the taper of the insert.The rim of the insert is chipped.However, it can be ascertained, whether the chip-off occurred already at the primary surgery, during in vivo load or during the revision surgery.On the polished surface of the insert an area of intensive metal abrasion can be found.The occurrence of this abrasion is a consequence of an intensive contact with the metal stem after the primary fracture event.On the polished surface of both components metal debris can be found obviously coming from small metal particles which have been smeared between the bearing surfaces.On the polished surface of the fragments of the ball head and on the inner sphere of the insert a clearly restricted area with increased wear can be found.However, it cannot be ascertained whether these areas were generated by microseparation/ edge loading prior to the fracture or caused by ceramic fragments and third-body-wear after the fracture event.Due to missing fragments and due to secondary damages, it cannot be drawn any conclusion regarding a possible cause for the fracture of the ball head.".

• Brand Name: BIOLOX PROSTHESIS HEAD 12/14 28MM S
• Type of Device: HIP ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10101360
• MDR Text Key: 195275318
• Report Number: 9610612-2020-00180
• 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
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

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: 06/01/2014
• Device Model Number: NK460
• Device Catalogue Number: NK460
• Device Lot Number: 51205758
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/14/2020
• Initial Date FDA Received: 05/29/2020
• Supplement Dates Manufacturer Received: 07/31/2020
• Supplement Dates FDA Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NH050T - 51223662; NH092 - 51205555; NK513T - 51225247
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR