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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG COREHIP VAR CEMENTLESS 12/14 SIZE 7 HIP ENDOPROSTHETICS

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AESCULAP AG COREHIP VAR CEMENTLESS 12/14 SIZE 7 HIP ENDOPROSTHETICS Back to Search Results
Model Number NK1047T
Device Problem Component or Accessory Incompatibility
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Manufacturing site evaluation: the provided devices were delivered in a contaminated condition. The components were decontaminated internally according to internal standards. Investigation: the available components were examined visually and microscopically. The case was also discussed with several specialists from the development department and specialists from the product management group. Only with repeated rotation in several directions with a lot of force was it possible to loosen the connection between the insertion instrument and the implant. The pocket in the implant (connection implant to instrument) show clearly visible material abrasions/damages on all 3 flanks. The working end of the insertion instrument also shows material damages. It was possible to readjust the error during the experiment/test. Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers and found to be according to specifications 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 as well as a result of our investigation the root cause of the failure is likely usage related. Rationale: according to the quality standard and device history record (dhr) files, a material defect and production error is improbable. At that we exclude a design related error because the market feedback is unremarkable on this matter. It was possible to readjust the error. It appears that the working end of the inserter was positioned in the pocket of the implant in an insufficient way by simultaneously using the hammer.

 
Event Description

It was reported that there was an issue with implant insertion. During a hip arthroplasty procedure, the implant and insertion instrument did not function together. It was noted that the insertion instrument did not detach from the implant. There was no patient harm or surgical delay. Another implant and instrument were used instead. Associated medwatches: (the implant and inserter were reported separately).

 
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Brand NameCOREHIP VAR CEMENTLESS 12/14 SIZE 7
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
lindsay chromiak
3773 corporate parkway
center valley , PA 18034
MDR Report Key8744451
Report Number9610612-2019-00439
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 06/28/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/28/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberNK1047T
Device Catalogue NumberNK1047T
Device LOT Number52489769
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/19/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date06/24/2019
Event Location No Information
Date Manufacturer Received06/05/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/10/2019
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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