MAUDE Adverse Event Report: AESCULAP AG VITELENE INSERT G 36MM POST.WALL; HIP ENDOPROSTHETICS

Model Number NV313E

Device Problems Migration or Expulsion of Device (1395); Material Integrity Problem (2978)

Patient Problems Joint Disorder (2373); Inadequate Osseointegration (2646)

Event Date 08/11/2020

Event Type  Injury  

Manufacturer Narrative

Investigation on going.Additional information / results will be submitted in a supplemental report.

Event Description

It was reported that there was an issue with vitelene insert.The original surgery was on (b)(6) 2011: total hip arthroplasty (tha), ceramic on ceramic.It was reported that the broken ceramic insert was completely broken into small pieces, and pe insert was selected as a replacement.Due to difficulty in removal of the screws upon removal of the plasmacup, the surgeon forcefully pulled the cup out of the acetabulum, leaving a relatively large bone defect in the acetabulum.The plasmacup was replaced with plasmafit and it was fixed with screws.The pe insert was also dislocated inside the plasmafit.Scratch marks were found in the rim of the plasmafit, and neck of the stem.Revision head sleeve showed no traces of damage.The plasmafit cup and the revision femoral head were replaced.The stem was not replaced because there was no replacement and of the surgical time that took longer than expected.Observation of the surgical site revealed metallosis.The revision was performed on (b)(6) 2020; the dislocation had been diagnosed on (b)(6) 2020 and the patient had difficulty walking.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).Invovled components: sleeve 8/10 xl f/biolox revision head - nj438t - 52481697, biolox delta revision head 12/14 36mm xl - nk638 - 52422313.

Manufacturer Narrative

If the device is received, the investigation will be updated.Investigation results: to date there is no device available for investigation.The device was not provided for investigation.Therefore a investigation of the device itself was not possible.The device history records have been checked for all available lot numbers and found to be according to the specification, valid at the time of production.There are no further complaints registered against the same lot numbers.On the basis of the current information and without the product for investigation, a clear conclusion can not be drawn.There is no indication for a material defect or manufacturing failure on the baisis of the device history records.Based on the investigations and results of the 8d report no capa is necessary.

Event Description

Position of involved and leading material has changed.Involved component: nj438t - sleeve 8/10 xl f/biolox revision head - lot: 52481697.Nk638 - biolox delta revision head 12/14 36mm xl - lot: 52422313.

• Brand Name: VITELENE INSERT G 36MM POST.WALL
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10522326
• MDR Text Key: 206958215
• Report Number: 9610612-2020-00512
• Device Sequence Number: 1
• Product Code: OQG
• 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: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: NV313E
• Device Catalogue Number: NV313E
• Device Lot Number: 52438663
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NJ438T - 52481697; NJ438T-52481697; NK638 - 52422313; NK638 - 52422313
• Patient Outcome(s): Required Intervention