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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG DC BIOLOX DELTA INSERT 32MM 48/50 SYM. HIP ENDOPROSTHETICS

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AESCULAP AG DC BIOLOX DELTA INSERT 32MM 48/50 SYM. HIP ENDOPROSTHETICS Back to Search Results
Model Number NH522D
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 biolox delta insert. 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).
 
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Brand NameDC BIOLOX DELTA INSERT 32MM 48/50 SYM.
Type of DeviceHIP ENDOPROSTHETICS
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer (Section G)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer Contact
christian von der grün
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key10380424
MDR Text Key207961206
Report Number9610612-2020-00407
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
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 Received08/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNH522D
Device Catalogue NumberNH522D
Device Lot Number52529914
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/11/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/07/2020 Patient Sequence Number: 1
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