MAUDE Adverse Event Report: AESCULAP AG PLASMACUP DC SIZE 50MM; HIP ENDOPROSTHETICS

Model Number NH550T

Device Problem Use of Device Problem (1670)

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

Event Date 06/24/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.This is a similar device report.A similar device was sold to us.

Event Description

It was reported that there was an issue with a plasmacup.According to the complaint description the implants involved in this complaint could not be fixed during surgery.During the total hip replacement (thr) the reamer instrument (fs960r and fs974) was damaged and was not fixed and wandered.The acetabulum cup portion has been reamed more than previously planned.Although nh548t was implanted first, it was replaced with nt550t because it was not fixed.All implants were removed because they were probably not fixed.An other implant of a competitor company was used.A pubis fracture occured during surgery.An additional medical intervention was necessary.Additional information was not provided nor available.The adverse event is filed under aag references (b)(4).Associated medwatch-reports: 9610612-2020-00405 (400480311 - nh550t) similar device sold to us.9610612-2020-00406 (400480315 - nh548t).9610612-2020-00407 (400480317 - nh522d).

Manufacturer Narrative

Additional information: two involved components were added to this complaint: fs960r - orthopilot tha reamer shank mpr harris - lot unknown.Fs974 - gloves protection f/fs959r/fs960r/fs961r - lot unknown.Associated medwatch-reports: (b)(4), 9610612-2020-00406 (b)(4), 9610612-2020-00407(b)(4).

Manufacturer Narrative

Based upon new information received, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.

• Brand Name: PLASMACUP DC SIZE 50MM
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10379944
• MDR Text Key: 207959846
• Report Number: 9610612-2020-00405
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NH550T
• Device Catalogue Number: NH550T
• Device Lot Number: 52521295
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FS960R LOT UNKNOWN.; FS974 LOT UNKNOWN.
• Patient Outcome(s): Required Intervention