MAUDE Adverse Event Report: AESCULAP AG BIOLOX PROSTHESIS HEAD 8/10 32MM M; HIP ENDOPROSTHETICS

Model Number NJ107

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problems Joint Disorder (2373); Insufficient Information (4580)

Event Date 05/29/2020

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.It was reported that there was a ceramic head fracture after a fall of the patient.A revision surgery was necessary.Additional information was available, about the circumstances of the break.Awareness date: (b)(6) 2020.The patient felt a creak while walking this morning at his prosthesis, he caught up on the worktop of his kitchen, he was able to drag himself to the living room to retrieve his cane.Prosthesis implanted 20 years ago, "functions badly" and squeaks for 10 years with difficulty to get up but the failure of the prosthesis got worse suddenly this morning.Pain in the crease of the groin and outer side of the thigh.The patient felt 15 days ago on his right hip with hematoma.Analgesic flexum.No pain in knee flexion position.Additional informtaion has been requested but not yet received as of this report.Additional patient information is not available.The adverse event/malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: three large and three very small fragments of a ceramic ball head were submitted.Ball head: density the density was determined on the fragments of the ball head.The measured density is complying with the delivery specification for biolox® components.Reconstruction the ceramic ball head cannot be completely reconstructed from the delivered fragments.There are fragments missing, which potentially could deliver further information if they were available.Metal transfer there are metal transfer patterns of erratic appearance on the polished surface and on the fracture surfaces.This secondary metal transfer was probably produced by rubbing between the metal parts and the ceramic fragments after the primary fracture event and during the surgical procedures.Such patterns do not provide any information about the cause of the fracture.In case of a symmetrical taper fit situation between the ceramic ball head and the metal taper, thin concentric lines (primary metal transfer) are expected over the whole circumference.The expected primary metal transfer cannot be found on the cone of the ball head.This indicates that the interface had been disturbed during the assembly of ball head and stem as it can be caused by contaminations like blood, bone particles or tissue, respectively.Such contaminations can lead to a decrease of the burst strength of the ball head.However, it cannot be ascertained whether this metal transfer occurred prior to or after the primary fracture event.Fracture surfaces obviously, fragments were rubbed against each other in the period between the primary failure event and the delivery of the fragments.Due to this mechanismintensive chipping occurred at fracture surface edges and on all fracture surfaces.Therefore, further information probably got lost which might have been helpful in the failure analysis.If the primary fracture event is caused by hoop stresses inside the conical bore of the ceramic ball head the primary fracture surface coincides with the ball head axis.Additionally, its appearance is very smooth and flat.Due to secondary damages and missing fragments the primary fractures surface and the fracture origin cannot be determined.Increased wear on the outer surface of the fragments clearly restricted areas with increased wear can be found.These wear zones could have been caused by micro-separation/ edge loading prior to the fracture event.The device history records have been checked for all available lot numbers and found to be according to the specification, valid at the time of production.There are no further complaints registered against the same lot numbers.Based on our experience of previous incidents, it might be possible that to much stress leaded to the breakage.Based on the investigations and results of the 8d report no capa is necessary.

• Brand Name: BIOLOX PROSTHESIS HEAD 8/10 32MM M
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10183841
• MDR Text Key: 196093876
• Report Number: 9610612-2020-00227
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K042344
• 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: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2006
• Device Model Number: NJ107
• Device Catalogue Number: NJ107
• Device Lot Number: 51094439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Weight: 104