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

Model Number NK460

Device Problem Break (1069)

Patient Problem Joint Disorder (2373)

Event Date 09/24/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information and 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 the patient feels a sudden creaking and pain in the right hip in a bent position.After diagnosis (x-ray) visible ceramic ball head fracture.On (b)(6) 2019 the revision with head and inlay change takes place.Implantation year is 2008.A revision surgery was necessary.Additional information was not provided nor available.The adverse event is filed under aag (b)(4).Involved components: nh092 - sc/msc ceramics insert 28mm 48/50 sym.- (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: we did receive the ceramic components for investigation.Investigation: four large, seven small and five very small fragments of a ceramic ball head as well as one large fragment of a ceramic insert were submitted.The density was determined on the fragments of the ball head.The measured density is complying with the delivery specification for biolox®forte components (3.96 g/cm3).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.Thus, there is a probability, that the analysis of the fragments and the fracture surface remains incomplete.Metal transfer of erratic appearance can be found on the outer 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.Such patterns do not provide any information about the cause of the fracture of the insert.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 primary metal transfer cannot be found equally distributed on the cone of the ball head.On two of the fragments the primary metal transfer cannot be evaluated due to secondary surface deterioration.Additionally, metal transfer can be found in region d/e.However, it cannot be ascertained whether this metal transfer occurred prior to or after the primary fracture event.Obviously, 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 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.A part of the primary fracture surfaces can be identified.The fracture origin cannot be determined due to the mentioned secondary damages and missing fragments.The insert is not broken but the rim is chipped.The chip-off fragment is not available.Metal transfer of erratic appearance can be found on the rim and on the inner sphere of the insert.This secondary metal transfer was probably produced by rubbing between metal parts and the ceramic insert after the primary fracture event 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 region g/h of the insert.Such metal transfer patterns can be found with varying intensity and not equally distributed on the provided insert.A part of the rim of the insert is chipped, see figure 8 red marking.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 of the ball head.On the outer surface of the fragments of the ball head and the inner surface of the insert a clearly restricted area with increased wear can be found.These wear zones potentially have been caused by edge loading or small ceramic fragments, respectively, which got into the bearing and were grinded further.Batch history review: 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: " 28-12/14 s-3.03 50201 iso 6474 " dots represent characters which are not available.Shop order: 7010196248 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 further complaints registered against the same aesculap lot number: 51152205.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 g/h: " 28/39 g 02 7591 iso 6474 " shop order: 7010185611 was identified for the insert based on this information.Protocols and acceptance certificate were reviewed.The quality documents show that the values obtained on the insert were according to the specification valid at the time of production.Conclusion and root cause: after the investigation of the components, a product related failure can be excluded.There are no signs for a material defect.We suspect that the failure is most probably patient related, e.G.Due to an overload situation.Rationale: 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 cannot be found equally distributed on the cone of the ball head.On two of the fragments the primary metal transfer cannot be evaluated due to secondary surface deterioration.A part of the primary fracture surface of the ball head can be identified.Due to secondary damages and missing fragments the fracture origin cannot be determined.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 outer surface of the fragments of the ball head and the inner surface of the insert a clearly restricted area with increased wear can be found.These wear zone potentially have been caused by edge loading or small ceramic fragments, respectively, which got into the bearing and were grinded further.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.The evaluation of the ceramic components is based on the investigation of the manufacturer of the ceramic components (company ceramtec gmbh, plochingen, germany).Data is filed under kiv 19 11 10 at ceramtec gmbh.Corrective action: according to sop sa-de13-m-4-2-04-000-0 (preventive action and corrective action) a capa is not necessary.Also additional information has been added to b5, implant date, explant date and lot number.Additional involved components: nh092 - sc/msc ceramics insert 28mm 48/50 sym.- 51148496.Nk512t - bicontact s plasmapore 12/14 size 12mm - 51158718.Nh048t - plasmacup sc size 48mm - 51167416.

Event Description

Due to reicept of the implant pass the following information has been added / updated: implant date, explant date, lot number and additional involved components additional involved components: nh092 - sc/msc ceramics insert 28mm 48/50 sym.- 51148496.Nk512t - bicontact s plasmapore 12/14 size 12mm - 51158718.Nh048t - plasmacup sc size 48mm - 51167416.

• Brand Name: BIOLOX PROSTHESIS HEAD 12/14 28MM S
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9349646
• MDR Text Key: 167404131
• Report Number: 9610612-2019-00777
• 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: 02/19/2020

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 Model Number: NK460
• Device Catalogue Number: NK460
• Device Lot Number: 51152205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 01/21/2020
• Supplement Dates FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NH048T - 51167416; NH092 - 51148496; NH092-500469931; NK512T - 51158718
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR