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

Model Number NK460

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 09/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Operative notes: pending translation.Manufacturing site evaluation: the component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of any pre-existing material defect.Due to a lack of ceramic parts, further investigation cannot be done at the moment.When additional informatoin becomes available, a supplemental report will be submitted.

Event Description

It was reported by the healthcare professional to the company sales representative "a ceramic head fracture occurred during a fall on sunday, (b)(6) 2018 the patient will be sent here by (b)(6).The initial surgery: (b)(6) 2001 and the revision surgery: (b)(6) 2018." additional information received on (b)(6) 2018: there was a corrected initial surgery date of (b)(6) 2001.Operative documents (to be translated) noted that the patient had complained of pain in the right hip and x-rays had confirmed the implant fracture on the (b)(6) 2018; the patient was then instructed to immobilize the hip in order to prevent further damage.The report also showed a revision date of (b)(6) 2018, not (b)(6) 2018.Diagnoses include mechanical complication of a hip prosthesis.During the revision, the inlay and head were replaced after the hip joint was debrided.The new head implant was 12/14 32mm s.At the end of the surgery, the right hip was treated with gentamicin irrigation.Additional information was received on (b)(6) 2018: the physician confirmed that the event did not occur because of a "fall".And the patient further clarified that he had been simply taking a walk and heard a "crack"; he did not mention a misstep or twisting motion.The patient condition was also reported to be "good" following the revision.The device will be returned.

Manufacturer Narrative

The density was determined on the fragments of the ball head according to din en623-2.The measured density is complying with the delivery specification for biolox forte components.The ceramic ball head cannot be completely reconstructed from the delivery fragments.There are fragments missing, which potentially could deliver further information if they were available.Thus, there is a probability, that the analysis of the fragments and the fracture surface remains incomplete.There are metal transfer pattern of erratic appearance on the polished surface and on the fracture surfaces which are clearly assigned to secondary effects, rubbing between the metal parts and the ceramic fragments after the primary fracture event.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 in region c.The expected metal transfer cannot be found.However, due to secondary surface deterioration the primary metal transfer cannot be evaluated.Fragments were rubbed against each other in the period between the primary failure event and the delivery of the fragments to ceramtec.Due to this mechanism intensive chipping occurred at fracture surfaces 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 fracture surfaces and the fracture origin cannot be determined.The insert is not broken.Metal transfer of erratic appearance can be found on the face and on the inner sphere of the insert.This secondary metal transfer was produced by rubbing between metal parts and the ceramic insert after the primary fracture events of the ball head or due to surgical procedure.Thus, it does not provide any information about the cause of the fracture.In case of a symmetrical taper fit situation between the ceramic insert and the metal cup, metal transfer patterns (primary metal transfer) are expected over the whole circumference in the region g/h of the insert.Such metal transfer patterns can be found on the insert.Furthermore, there are erratic metal transfer patterns on the taper which potentially occurred during the removal of the insert from the metal cup at the revision surgery.On the polished surface of the insert an area of intensive metal abrasion can be found.The occurrence of the abrasion is a consequence of an intensive contact with the metal stem after the primary fracture event of the ball head.The insert does not provide any hint regarding a possible cause of the failure of the ball head.Clearly restricted areas with increased wear can be found on the outer surface of the fragments of the ball head and the inner surface of the insert.However, it cannot be decided clearly, 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.The identification of the provided ball head is completely possible by reading off the laser engraving.The following elements of the engraving can be read, indicated on the outer chamfer.Dots represent characters which are not available.Shop order 7010136524 was identified for the ball head based on this information.Protocols and acceptance certificate were reviewed.The quality documents show that the values obtained on the ball head were according to the specification valid at the time of production.No similar complaints have been filed with products from the batch of the ceramic ball head.The identification of the provided insert is completely possible by reading off the laser engraving.The following elements of the engraving can be read, indicated on the outside surface.Shop order 7010140322 was identified for the insert based on this information.Protocols and acceptance certificate were reviewed.The quality documents shows that the valves obtained on the insert were according to the specification valid at the time of production.The failure is most probably usage/ patient related.A capa is not necessary.

• 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: 7975949
• MDR Text Key: 124064306
• Report Number: 9610612-2018-00467
• 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: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2006
• Device Model Number: NK460
• Device Catalogue Number: NK460
• Device Lot Number: 51109812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Distributor Facility Aware Date: 11/21/2018
• Device Age: 17 YR
• Date Manufacturer Received: 11/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 88