MAUDE Adverse Event Report: AESCULAP AG ISODUR PROSTHESIS HEAD 8/10 32MM L; HIP ENDOPROSTHESES - HEADS

Model Number NJ128K

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Joint Dislocation (2374)

Event Date 08/28/2019

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 the product isodur prosthesis head 8/10 32mm l.A revision surgery was necessary due to dislocation 10 months postoperatively.The surgeon had attempted to reposition, but the pe liner accidentally disengaged from the plasma cup.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2019-00801.

Manufacturer Narrative

Investigation the pe-insert as well as the metal ball head has been analysed visually and microscopically.Metal ball head - nj128k.On the outer surface as well as on the chamfer of the metal ball head, a multitude of scratches and damages can be found, it can not be decided clearly whether these damages occurred during/after the implantation, or during/after the revision surgery.Pe-insert - nv301e.On the outer surface of the pe-insert, partial damage and scratches of erratic appearance can be found.A conspicuous dent can be found above the shoulder, probably caused by the bore hole on the plasmacup metal shell.This indicates that high forces were applied to the pe-insert during or after the implantation.The taper is worn/scratched over the whole circumference.This may indicate that the insert rotated within the metal shell.Furthermore the shoulder is partially damaged.Additionally the inner surface shows scratches/damages too.It can not be decided clearly whether these damages occurred during/after the implantation, or during/after the revision surgery.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.There is no indication for a material defect of a manufacturing failure.No further complaints registered against the same lot numbers.Conclusion and root cause: the failure is most probably usage related.Rationale: on the basis of the provided information and after the investigation, there is no indication for a material defect or manufacturing error.The pe-insert as well as the meal ball head are showing several damages which occurred after the distribution.Both components are worn.It remains unknown what ultimately caused the luxation.It is possible that the implantation situation was inappropriate, e.G.Due to a non-optimal inclination (too flat or too steep).However, without x-ray pictures this is only an assumption.On the basis of the market surveillance and statistical analysis, there is no hint for a systematic failure.Corrective action a capa is not necessary.

• Brand Name: ISODUR PROSTHESIS HEAD 8/10 32MM L
• Type of Device: HIP ENDOPROSTHESES - HEADS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9410775
• MDR Text Key: 169084400
• Report Number: 9610612-2019-00802
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: K122783
• 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: 02/20/2020

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: Lay User/Patient
• Device Model Number: NJ128K
• Device Catalogue Number: NJ128K
• Device Lot Number: 52127503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 12/04/2019
• Supplement Dates Manufacturer Received: 01/27/2020
• Supplement Dates FDA Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention