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

Model Number NK460

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Joint Disorder (2373)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: preliminary investigation: the ceramic components have been provided and forwarded to the manufacturer (ceramtec (b)(4)) for further investigation.Results pending.The device history records for the lot number (51130227) has been checked and found to be according to the specification, valid at the time of production.No similar complaints have been registered against the same lot number.Due to the fact that the investigation is still ongoing, a final conclusion can not be drawn to date.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the biolox prothesis head, requiring explant.The following information was provided: the hip implant system was placed in 2002.A plasmafit cup 56 mm, ceramic inlay 44-28 and ceramic head 12/14 28 mm on spotorno (manufactured by zimmer) shaft were used.Recently, the patient experienced sudden cracking and pain in the hip joint.As a result, the system was explant and changed to pe inlay with intact cup and metal head with merete adapter with 12/14 cone with fixed stem.Associated components: sc/msc ceramics insert 28mm 56/58 sym.Plasmacup sc size 56mm implant from competitor:.Ref.29.00.39-137, cls stem 135°, lot 2124525, protek sulzer medica.The adverse event is filed under (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: we received a complaint about a nk460 - biolox prosthesis head 12/14 28mm s regarding a post-operative event.The ceramic components have been provided and forwarded to the manufacturer for further investigation.Primary surgery: 11.11.2002 revision surgery: 01.07.2019 implantation period: 187 months and 20 days concequences for the patient post-operative medical intervention was necessary.Investigation three large and one small fragment of a ceramic ball head as well as one large fragment of a ceramic insert 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 (> 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 metal transfer of erratic appearance can be found on the outer surface and on the fracture surfaces, see figure 2.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 (see appendix).The expected primary metal transfer can be found only slightly existing on the cone of the ball head, see figure 3 red marking.On one of the fragments the primary metal transfer cannot be evaluated due to secondary surface deterioration, see figure 3 white marking.Additionally, metal transfer can be found in region d/e, see figure 3 blue marking.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, see.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 andmissing 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.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 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 only slightly existing and not equally distributed on the provided insert.Additionally, metal transfer can be found on the transition i/j, fracture surface a part of the rim of the insert is chipped.The edges of the fracture surface are rounded to the inner sphere.That indicates that the chip-off had been caused a longer time prior to the revision surgery.However, it can be ascertained, whether the chip-off was caused due to recurring subluxations of the ball head or by a contact with the metal stem taper after the fracture of the head.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.Increased wear.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 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 lot number.Conclusion and root cause based on the investigation, a product/material related failure could not be detected.We assume that the failure is most probably patient (overload situation) or usage (implantation situation) related.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 can be found only slightly existing on the cone of the ball head.On one of the fragments the primary metal transfer cannot be evaluated due to secondary surface deterioration.· due to secondary damages and missing fragments the primary fracture surfaces and fracture origin cannot be identified on the fragments of the ball head.· primary metal transfer can be found only slightly existing and not equally distributed on the taper of the insert.· the rim of the insert is chipped.The edges of the fracture surface are rounded to the inner sphere.That indicates that the chip-off had been caused a longer time prior to the revision surgery.However, it can be ascertained, whether the chip-off was caused due to recurring subluxations of the ball head or by a contact with the metal stem taper after the fracture of the head.· 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 zones 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).According to our ifu, it is not allowed to combine aesculap products with competitor products.Corrective action according to sop sa-de13-m-4-2-04-000-0 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: 8855845
• MDR Text Key: 153140439
• Report Number: 9610612-2019-00527
• 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: 11/12/2019

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: 04/01/2007
• Device Model Number: NK460
• Device Catalogue Number: NK460
• Device Lot Number: 51130227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2019
• Initial Date Manufacturer Received: 07/04/2019
• Initial Date FDA Received: 08/02/2019
• Supplement Dates Manufacturer Received: 10/08/2019
• Supplement Dates FDA Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 137CLS STEM 135°PROTEK; 137CLS STEM 135°PROTEK; NH094 - SC/MSC 28MM; NH094 - SC/MSC 28MM; PLASMACUP SC SIZE 56MM; PLASMACUP SC SIZE 56MM; 137CLS STEM 135°PROTEK; NH094 - SC/MSC 28MM; PLASMACUP SC SIZE 56MM
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR