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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS BIOLOX DELTA PROSTH.HEAD 8/10 36MM S MPLANTS STANDARD PROSTHESES HEADS

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AESCULAP IMPLANT SYSTEMS BIOLOX DELTA PROSTH.HEAD 8/10 36MM S MPLANTS STANDARD PROSTHESES HEADS Back to Search Results
Model Number NJ116D
Device Problems Material Discolored (1170); Material Integrity Problem (2978)
Patient Problem Post Operative Wound Infection (2446)
Event Date 12/18/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Manufacturing site evaluation: evaluation on-going.

 
Event Description

(b)(6). Two months after the primary surgery, the symptom looked like metallosis was appeared. Therefore, the revision surgery was done. The grayish discoloration at the implant area was seen. Additionally, blackish powdery metal material was found on the outside of stem neck. Regarding the stem neck, any damages were not found. The revision surgery was done by using 36mm delta ceramic head. The customer carried out the biopsy for the metal material and found it could be a metal material. The patient showed symptoms of infection first. This is the reason for the revision surgery. Upon visualizing the implanted components, the surgeon noticed discolored tissue around the stem neck. The discoloration was found to be metallosis after the tissue sample was tested in the hospital. The patient showed symptoms of infection only two months after the primary surgery. She received no other surgical intervention in the interim. Components in use listed as concomitant devices are: nj116d / biolox delta prosth. Head 8/10 36mm s, nj632t / bicontact e plasmapore-¿cap 8/10 sz. 12h, nv313e / vitelene insert g 36mm post. Wall, nc952t / plasmafit plus 7 cup cap size 52mm g.

 
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Brand NameBIOLOX DELTA PROSTH.HEAD 8/10 36MM S
Type of DeviceMPLANTS STANDARD PROSTHESES HEADS
Manufacturer (Section D)
AESCULAP IMPLANT SYSTEMS
po box 40
tuttlingen, 78501
GM 78501
Manufacturer (Section G)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer Contact
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key7226639
MDR Text Key98630004
Report Number9610612-2018-00036
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK082991
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/02/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/29/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberNJ116D
Device Catalogue NumberNJ116D
Device LOT Number52328661
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/16/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date01/16/2018
Device Age9 mo
Event Location No Information
Date Manufacturer Received01/09/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/13/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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