MAUDE Adverse Event Report: AESCULAP AG BIOLOX DELTA PROSTH.HEAD 12/14 36MM L; HIP ENDOPROSTHESES - HEADS

Model Number NK652D

Device Problem Fracture (1260)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/09/2020

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 delta prosth.Head 12/14 36 mm l.According to complaint description it was reported the following: the patient, during normal daily activities, suddenly had shooting pain, feeling of instability in the left leg and inability to walk.After 9 year, 9 month there was postoperative (po) fracture of ceramic ball head.A revision surgery was necessary.Additional information was not provided nor available.The adverse event is filed under aag reference (b)(6).Involved components: nk652d - biolox delta prosth.Head 12/14 36 mm l - batch 51672173.Nh109d - sc/msc biolox delta ins.36 mm 56/58 sym.- batch 51676875.Nc286t - metha cap 12/14 135°/0° size 6 - batch 51472758.Nh056t - plasmacup sc size 56 mm - batch 51659564.

Manufacturer Narrative

A - patient data updated.General information: according to the provided information, we will receive the components for investigation.They will be forwarded to the manufacturer of the ceramic components (ceramtec gmbh, plochingen).Afterwards this report will be updated after the investigation has been executed.Involved components: nk652d - biolox delta prosth.Head 12/14 36mm l - batch 51672173.Nh109d - sc/msc biolox delta ins.36mm 56/58 sym.- batch 51676875.Nc286t - metha cap 12/14 135°/0° size 6 - batch 51472758.Nh056t - plasmacup sc size 56mm - batch 51659564.Consequences for the patient: post-operative medical intervention was necessary - revision surgery.Investigation: investigation ongoing.Pictorial documentation: investigation ongoing.Batch history review: the device history records have been checked for the available lot numbers and found to be according to the specification, valid at the time of production.No further complaints registered against the same lot number (51672173).Conclusion and root cause: to date, we suspect that the failure is most probably usage or patient related.There is no indication for a material or manufacturing failure.However, the investigation is still ongoing.This report will be updated after the investigation has been executed.Rationale: refer to conclusion and root cause.

Manufacturer Narrative

The device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.Explanation and 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.There are no indications of any pre-existing material defect.· secondary metal transfer patterns can be found on the fragments of the ball head as a result of contact with metal parts and/ or surgical instruments after the fracture event.· the expected primary metal transfer can be found 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.Parts of the primary fracture surfaces and the region of the fracture origin can be identified.Due to secondary damages the fracture origin cannot be determined on the fragments of the ball head.· due to missing fragments and secondary damages, it cannot be drawn any conclusion regarding a possible cause for the fracture of the ball head.

• Brand Name: BIOLOX DELTA PROSTH.HEAD 12/14 36MM L
• Type of Device: HIP ENDOPROSTHESES - HEADS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10101471
• MDR Text Key: 193654450
• Report Number: 9610612-2020-00179
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K082991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2020

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: 05/31/2020
• Device Model Number: NK652D
• Device Catalogue Number: NK652D
• Device Lot Number: 51672173
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/14/2020
• Initial Date FDA Received: 05/29/2020
• Supplement Dates Manufacturer Received: 06/05/2020; 09/07/2020
• Supplement Dates FDA Received: 06/30/2020; 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NC286T - BATCH 51472758.; NH056T - BATCH 51659564.; NH109D - BATCH 51676875.; NK652D - BATCH 51672173
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR