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

Model Number NK460

Device Problem Fracture (1260)

Patient Problem Joint Disorder (2373)

Event Date 04/17/2020

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 a biolox prosthesis head.In complaint report was reported that a spontaneous ceramic head fracture with a ceramic-ceramic sliding combination occurred.There is no involvment with an inlay or conus.The complaint relates only to the ceramic head.Likewise no causation by a trauma was found.During shoe tying the patient noticed cracking noises and felt pain.A revision surgery was necessary.The adverse event is filed under aag reference (b)(4).Involved components: nh056t - plasmacup sc size 56mm - 51179400.Nh094 - sc/msc ceramics insert 28mm 56/58 sym.- 51149043.Nk513t - bicontact s plasmapore 12/14 size 13mm - 51172055.

Manufacturer Narrative

Conclusion and root cause: based on the information available and after the investigation it is not possible to determine a definitive root cause for the failure.Rationale: there are no indication of a material defect.Due to missing fragments and secondary damages, it cannot be drawn any conclusion regarding a possible cause for the fracture of the ball head.The evaluation of the ceramic components is based on the investigation of the manufacturer of the ceramic components (company ceramtec gmbh, plochingen, germany).

• 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
• MDR Report Key: 10075234
• MDR Text Key: 195406186
• Report Number: 9610612-2020-00164
• 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: 07/23/2020

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: 02/01/2008
• Device Model Number: NK460
• Device Catalogue Number: NK460
• Device Lot Number: 51158489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Initial Date Manufacturer Received: 04/30/2020
• Initial Date FDA Received: 05/20/2020
• Supplement Dates Manufacturer Received: 06/26/2020
• Supplement Dates FDA Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NH056T -NH094 - NK513T -
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR