MAUDE Adverse Event Report: AESCULAP AG COLLECT.NO.QAS FEM.HEADS BIOLOX; HIP ENDOPROSTHESES - HEADS

Model Number AE-QAS-H547-01

Device Problems Fracture (1260); Migration (4003)

Patient Problem Joint Disorder (2373)

Event Date 05/05/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: we received a complaint about a broken ceramic ball head.According to the provided information, the ball head was implanted in the year 2000.No further information is available.We did not receive the broken ball head for investigation.Investigation: due to a lack of components, an investigation is not possible.Batch history review: due to the fact that neither an article number nor a lot number was provided, a review of the device history records must remain incomplete.Conclusion and root cause: the failure is most probably patient related.Rationale: due to the fact that we did not receive the components nor further information for an investigation, a clear conclusion can not be drawn.However, based on our experience we suspect that the root cause is most likely patient related (e.G.Due to overload) after this long amount of implantation time.Corrective action: a capa is not necessary according to sop (b)(4) (corrective action and preventive action).

Event Description

It was reported that there was an issue with a ceramic femoral head.According to the reporter there was a fracture of the ceramic ball head 20-years postoperatively; with horizontal hip, total hip replacement (tep).A revision surgery was necessary.An additional medical intervention was necessary.Additional information was provided in form of preoperative x-rays, which did not show the fracture (before initial implantation).The adverse event is filed under aag reference (b)(4).Involved components: ae-qas-h547-01 - ollect.No.Qas fem.Heads biolox.Nk515t - bicontact s plasmapore 12/14 size 15mm - 51051901.Ae-qas-h548-01 - collect.No.Qas acetab.Cups biolox.

Manufacturer Narrative

General information: we did receive the broken ball head, a ceramic insert as well as a metal stem for investigation.They have been forwarded to the manufacturer of the ceramic components ceramtec gmbh, plochingen.Aesculap components have been combined with components from competitors.Such a combination is not tested nor approved by aesculap.Consequences for the patient: post-operative medical intervention was necessary à revision surgery.Failure description: three large fragments of a ceramic ball head, one large fragment of a ceramic insert and a metal stem were submitted.Investigation: density.The density was determined on the fragments of the ball head and on the fragment of the insert.The measured density of both components is complying with the delivery specification for biolox®forte components.Ball head.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.Thus, there is a probability, that the analysis of the fragments and the fracture surface remains incomplete.Metal transfer.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 ball head.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 equally distributed on the cone of the ball head and the taper surface shows partly intensive deterioration.Due to this secondary surface deterioration, the primary metal transfer pattern cannot be evaluated comprehensively.Additionally, metal transfer can be found.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 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.Due to secondary damages and missing fragments the primary fractures surface and the fracture origin cannot be determined.Insert.Reconstruction: the insert is not broken but the rim is chipped.The chip-off fragments are not available.Metal transfer.Metal transfer of erratic appearance can be found on the outer surface and on the inner sphere of the insert, see figure 5.This secondary metal transfer was produced by rubbing between metal parts and the ceramic insert after the primary fracture event of the ball head or due to surgical procedures.Thus, it does not provide any information about the cause of the fracture.Intensive metal transfer can be found on the rim of the insert.This metal transfer might indicate impingement between the metal stem and the ceramic insert.However, it cannot be ascertained whether this impingement occurred prior to or after the primary fracture event.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 of the insert.Such metal transfer patterns can be found with varying intensity on the provided insert.Additionally, metal transfer can be found on the transition.Fracture surface.The rim of the insert is chipped.The appearance of the fracture surface (rounded to the inner sphere) indicates that the chip-off could have been caused due to edge-loading and/ or recurring subluxations of the ball head leading to multiple, secondary chip offs at the rim of the insert.Furthermore, a second part of the rim of the insert is chipped.However, it can be ascertained, whether the chip-off was caused by impingement between the metal stem and the ceramic insert or during the extraction of the insert out of the metal cup at the revision surgery.Metal abrasion.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.Metal stem.On the provided metal stem intensive damages can be found in the taper region.These damages on the metal stem indicate an intensive contact with fragments of the broken ball head and the bearing sphere of the ceramic insert over a longer time prior to the revision surgery.Due to the fact that the taper surface of the metal stem is severely damaged, no further information regarding a potential fracture reason can be acquired from the metal stem.Batch history review.Ball head: the identification of the provided ball head is not possible by reading off the laser engraving.No elements of the engraving can be read, indicated on the outer chamfer.No information were provided for the identification of the component.Without any information no shop order could be identified for the ball head.Thus, protocols and acceptance certificates cannot be reviewed.Insert (competitor - eska).The identification of the provided insert is completely possible by reading off the laser engraving.Shop order (b)(4) 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: the failure is most probably patient/usage related.Rationale: · the density of the ball head and insert was analysed and found to be complying with the delivery specification for biolox®forte components.The microstructure as obtained from the quality documents of the insert 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, and the taper surface shows partly intensive deterioration.Due to this secondary surface deterioration, the primary metal transfer pattern cannot be evaluated comprehensively.· due to secondary damages and missing fragments the primary fracture surfaces and fracture origin cannot be identified on the fragments of the ball head.· intensive metal transfer on the rim of the insert might indicate impingement between the metal stem and the ceramic insert.However, it cannot be ascertained whether this impingement occurred prior to or after the primary fracture event.· primary metal transfer can be found with varying intensity on the taper of the insert.· the rim of the insert is chipped.The appearance of one of the fracture surfaces (rounded to the inner sphere) indicates that the chip-off could have been caused due to edge-loading and/ or recurring subluxations of the ball head leading to multiple, secondary chip offs at the rim of the insert.A second part of the rim of the insert is chipped, too.However, it cannot be ascertained, whether this chip-off was caused by impingement between the metal stem and the ceramic insert or during the extraction of the insert out of 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 this abrasion is a consequence of an intensive contact with the metal stem after the primary fracture event over a long time prior to the revision surgery.· on the provided metal stem intensive damages can be found in the taper region.This indicates an intensive contact with fragments of the broken ball head and the ceramic insert over a longer time prior to the revision surgery.· the metal stem does not provide any hint regarding a possible cause of the failure of the components.· 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 (b)(4) at ceramtec gmbh.

• Brand Name: COLLECT.NO.QAS FEM.HEADS BIOLOX
• Type of Device: HIP ENDOPROSTHESES - HEADS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9786221
• MDR Text Key: 182307994
• Report Number: 9610612-2020-00030
• 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: 06/29/2020

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: AE-QAS-H547-01
• Device Catalogue Number: AE-QAS-H547-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 03/04/2020
• Supplement Dates Manufacturer Received: 06/05/2020
• Supplement Dates FDA Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AE-QAS-H547-01.; AE-QAS-H548-01.; NK515T - 51051901
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR