• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH ALLOFIT-S ALLOCLASSIC SHELL 50/HH ALLOFIT ACETABULAR SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER GMBH ALLOFIT-S ALLOCLASSIC SHELL 50/HH ALLOFIT ACETABULAR SYSTEM Back to Search Results
Catalog Number 4264
Device Problems Component Missing; Thread
Event Date 07/23/2015
Event Type  Other  
Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review. Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming. A cause for this specific event cannot be ascertained from the information provided. Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted. Zimmer's reference number of this file is (b)(4).

 
Event Description

It was reported that the surgeon was trying to implant an allofit-s alloclassic shell 50/hh but the threaded hole, which allows the attachment to the handle impactor, was partially devoid of the thread which creates locking. After a couple of tries and a delay of the surgery for about ten minutes, the surgeon asked to replace the cup with a greater size, not having a doubling of the same.

 
Manufacturer Narrative

As the device was not at hand for investigation, a technical investigation was not possible to perform, the device manufacturing quality records indicate that the released components met all requirements to perform as intended. No trend identified. The compatibility check could not be performed as only one product was reported to us. The product compatibility check is not relevant for one product only. Review of incoming information: it was reported that during surgery, the surgeon performed several attempt to attach the handle impactor to the allofit cup without success. The thread of the cup got damaged and therefore was necessary to replace it. Since the surgeon did not want the doubling of the same, a bigger size cup was chosen and it worked fine. Except of the surgery delay of 10 minutes, no other harms for patient. Possible causes for the reported event according to dfmea: line 23 : damage of the shell (cause: impaction during implantation or revision) -> due to high load due to impaction during the primary implantation or revision; line 25 : difficulties to assemble components -> due to high load due to impaction during the primary implantation or revision leading to damage of the screw plug; line 26 : difficulties to assemble components -> due to high load due to impaction during the primary implantation or revision leading to damage of the polar plug; line 27 : difficulties to assemble components -> due to high load due to impaction during the primary implantation or revision leading to damage of the screw thread of the shell; line 28 : difficulties to assemble components -> due to screw assembling force leading to damage bone screw; line 29 : fracture of the pelvis (cause: impaction during implantation) -> due to high load due to impaction during the primary implantation or revision; line 61 : wrong combination of the components -> due to lms marking is not readable under or lighting, marking parameters are not sufficient. 2. Comparison to investigation results whether it is possible and justification: line 23 : not possible -> it is reported that the surgeon had not yet impacted. Was only triing to screw the shell on the isntrument; line 25 : not possible -> it is reported that the surgeon had not yet impacted. Was only triing to screw the shell on the isntrument; line 26 : not possible -> it is reported that the surgeon had not yet impacted. Was only triing to screw the shell on the isntrument; line 27 : not possible -> it is reported that the surgeon had not yet impacted. Was only triing to screw the shell on the isntrument; line 28 : possible -> as it is reported that the issue occured when surgeon was triing to screw the shell on the isntrument; line 29 : not possible -> it is reported that the surgeon had not yet impacted. Was only triing to screw the shell on the isntrument; line 61 : possible -> product(s) where not returned. Therefore, cannot be excluded. Based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced. The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed. Zimmer's reference number of this file is (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameALLOFIT-S ALLOCLASSIC SHELL 50/HH
Type of DeviceALLOFIT ACETABULAR SYSTEM
Manufacturer (Section D)
ZIMMER GMBH
sulzerallee 8
winterthur 8404
SZ  8404
Manufacturer Contact
kevin escapule
p.o. box 708
warsaw , IN 46581-0708
5742676
MDR Report Key4991434
Report Number9613350-2015-00966
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation PHYSICIAN
Type of Report Initial,Followup
Report Date 07/23/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/07/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2020
Device Catalogue Number4264
Device LOT Number2801322
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2015
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: 08/07/2015 Patient Sequence Number: 1
-
-