MAUDE Adverse Event Report: AESCULAP AG VITELENE INSERT L 36MM SYM.; HIP ENDOPROSTHETICS

Model Number NV218E

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/12/2020

Event Type  Injury  

Manufacturer Narrative

This is a similar device report.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 a vitelene insert.According to the complaint description the inlay could repeatedly not be clamped symmetrically in the plasmafit cup.The inlay tilted after insertion.Another cup was used to finish surgery and the third inlay attempted was implanted.An additional medical intervention was necessary.Additional information was not provided nor available.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Involved components: nv060t - plasmafit poly cup size 60mm l - lot 52607037.

Manufacturer Narrative

Investigation results: the components were examined visually and microscopically with the digital microscope.This case was discussed with a specialist from the product management.The plasmafit poly cup with the inserted vitelene insert and another vitelene insert was provided to us for investigation.We do not know how the explants were decontaminated in the hospital.In case of thermal decontamination, the probability is very high that there will be a slight change in dimensions of the plastic components (vitelene insert).The first test shows that the inlay is firmly seated in the cup.The edge of the inlay extends approx.0.1 mm beyond the edge of the cup.An explicit overhang on one side cannot be determined.The inlay is damaged on one side.This results from the trying to separate the inlay from the cup.The cup also shows damages at the edge.This probably happened when the first inlay was removed from the cup.The inlay which was first removed out of the cup shows also damages at the edge.This happened when the inlay was taken out of the cup.This inlay shows an uneven wear pattern on the underside at the transition from radius to cone.Batch history review 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.There are no similar complaints against the same lot number(s) with this error pattern.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based on the visual analysis of the provided devices, as well as received information and consultation with the product management it could be possible that the plasmafit poly cup was minimally deformed when hitting in the acetabulum.This only occurs when the pressfit is very strong (heavy clamping in the acetabular hard bone substance).Based upon the investigations results there is capa is not necessary.

• Brand Name: VITELENE INSERT L 36MM SYM.
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10477360
• MDR Text Key: 205274855
• Report Number: 9610612-2020-00441
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

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: NV218E
• Device Catalogue Number: NV218E
• Device Lot Number: 52589283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 09/17/2020
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NV060T - LOT 52607037
• Patient Outcome(s): Required Intervention