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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS BIOLOX DELTA PROSTH.HEAD 12/14 28MM M HIP ENDOPROSTHETICS

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AESCULAP IMPLANT SYSTEMS BIOLOX DELTA PROSTH.HEAD 12/14 28MM M HIP ENDOPROSTHETICS Back to Search Results
Model Number NK461D
Device Problems Material Discolored; Material Disintegration; Material Fragmentation; Device Dislodged or Dislocated
Event Type  Malfunction  
Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going.

 
Event Description

Country of complaint: (b)(6). The patient was diagnosed with congenital hip dislocation (left side). The patient's first operation was at age two, since then the patient has had several operations from childhood to adolescence years. At age (b)(6) the patient was diagnosed with osteoarthritis of the hip (left side). On (b)(6) 2011 patient underwent a total hip replacement with cementless femoral component, excia 12/14 cementless and plasmacup sc with (2) screws. The position and size of the biolox delta ceramic was correct. The position of the cup was vertical, and resulting in an unstable replacement. In reviewing the prosthesis it was noticed that there was a dark colored tissue reaction similar to metallosis was found. There was fragments of the head and rim. Components in use listed as concomitant devices are: nk461d / biolox delta prosth. Head 12/14 28mm m; nh091d / sc/msc biolox delta ins. 28mm 44/46 sym; na774t / plasmacup fixation screw 6. 5x24mm (2); nh046t / plsmacup sc size 46mm.

 
Manufacturer Narrative

Investigation: an investigation was not possible due to the lack of the complained components. Batch history review: 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. No similar incidents have been filed with products from these batches. Conclusion and root cause: based on the information available and as a result of our investigation, a product related failure can be excluded. The failure is most probably user related. Rational: the x-ray pictures show the cup component in a highly inclined position. The cup inclination was estimated to be larger than 65 degrees. For acetabular shells which are too steep, surface pressure on the acetabular edge increases. This can lead to increased wear and tear. According to the instructions for use: "the inclination of the socket component should not be significantly more or less that 40-45 degrees. " no capa is necessary.

 
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Brand NameBIOLOX DELTA PROSTH.HEAD 12/14 28MM M
Type of DeviceHIP ENDOPROSTHETICS
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 Key6126082
Report Number3005673311-2016-00194
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Type of Report Initial,Followup
Report Date 04/12/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/23/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/01/2020
Device MODEL NumberNK461D
Device Catalogue NumberNK461D
Device LOT Number51689435
Was Device Available For Evaluation? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date11/03/2016
Device Age6 yr
Event Location No Information
Date Manufacturer Received10/27/2016
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/23/2016 Patient Sequence Number: 1
Treatment
NA774T / PLASMACUP FIXATION SCREW 6.5X24MM (2)
NH046T / PLASMACUP SC SIZE 46MM
NH091D / SC/MSC BIOLOX DELTA INS. 28MM 44/46 SYM
NK461D / BIOLOX DELTA PROSTH. HEAD 12/14 28MM M
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