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

Catalog Number 4264

Device Problem Component Missing (2306)

Patient Problem No Code Available (3191)

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).

• Brand Name: ALLOFIT-S ALLOCLASSIC SHELL 50/HH
• Type of Device: ALLOFIT 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 Key: 4991434
• MDR Text Key: 22864386
• Report Number: 9613350-2015-00966
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 4264
• Device Lot Number: 2801322
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR