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

Model Number NK461

Device Problem Fracture (1260)

Patient Problems Joint Disorder (2373); Device Embedded In Tissue or Plaque (3165)

Event Date 03/07/2020

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 product biolox prosthesis head 12/14 28mm m.According to complaint report there was reported that the patient needed a hip "tep" treatment on the left side in 2008.After falling over a vacuum cleaner on (b)(6) 2020 the hip twisted and there was a crackling felt.After this incident mechanical noises and crunching heard in the left side hip area was noticed by patient.Clinical and radiological diagnostics were made and showed the fracture of the modular ceramic head in ceramic-polyethylene sliding pairing.X-rays has been provided by hospital.A revision surgery was necessary.It was confirmed that no implant stickers or the hospital documentation are available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Section d, product information including batch.Manufacturing site evaluation: failure description: four large and seven small fragments of a ceramic ball head as well as a pe-insert were submitted.Investigation - 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®forte components (>= 3.96 g/cm3).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 polished surface and on the fracture surfaces of the ceramic ball head.This secondary metal transfer was probably produced by rubbing between 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 are expected over the whole circumference in the region c.The expected primary metal transfer can be found with varying intensity on the cone of the ball head.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.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.Investigation - pe-insert abrasion on the inner sphere of the pe-insert indicates a contact with the broken fragments of the ball head and the metal stem.The pe-insert does not provide any hint regarding a possible cause of the fracture of the ball head.Batch history review: the identification of the provided fragments of the 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 surface "i"." 28-12/1.M 08 166931 iso.74 " dots represent characters which are not available.Shop order 7010518169 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 specifications valid at the time of production.(b)(4) pieces were delivered to aesculap under the following lot number: lot 51487055 no further complaints registered against the same lot number.Conclusion and root cause: the failure is most probably patient related.Rationale: the density of the ball head was analysed and found to be complying with the delivery specification for biolox® components.The microstructure as obtained from the quality documents fulfils the requirements as specified at the time of production, too.There are no indications of any pre-existing material defect.Secondary metal transfer as a result of contact with metal parts after the fracture event can be found on the ball head.The expected primary metal transfer can be found with varying intensity on the bore of the ball head.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.Due to secondary damages and missing fragments the fracture origin cannot be identified on the fragments of the ball head.Abrasion on the inner sphere of the pe-insert indicates a contact with the broken fragments of the ball head.The pe-insert does not provide any hint regarding a possible cause of the failure of the ball head.The reported fall of the patient most likely caused the fracture of the ceramic ball head.Corrective action: according to sop sa-de13-m-4-2-04-000-0 (preventive action and corrective action) a capa is not necessary.

• Brand Name: BIOLOX PROSTHESIS HEAD 12/14 28MM M
• Type of Device: HIP ENDOPROSTHESES - HEADS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9938034
• MDR Text Key: 187417248
• Report Number: 9610612-2020-00135
• 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: 07/16/2020

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 Expiration Date: 06/30/2018
• Device Model Number: NK461
• Device Catalogue Number: NK461
• Device Lot Number: 51487055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Initial Date Manufacturer Received: 03/17/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 06/23/2020
• Supplement Dates FDA Received: 07/16/2020
• 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