MAUDE Adverse Event Report: ZIMMER GMBH AVENIR MULLER, STEM, STANDARD, UNCEMENTED, HA, 6, TAPER 12/14; AVENIR MULLER STEM

Model Number N/A

Device Problem Difficult To Position (1467)

Patient Problem No Code Available (3191)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that, during surgery on (b)(6) 2017 to implant avenir muller, stem, standard, uncemented, ha, 6, taper 12/14 on the left side, avenir stem sat proud several millimeters so no hip reduction could be done.Hence it was decided to rebroach the femur to sink stem deeper.Surgery was completed with taperloc stem -biolox head.Notes: the implantation and explantation dates are left empty as the device involved in this complaint is damaged.Hence, no explantation date is captured, for the same reason.

Manufacturer Narrative

Investigation results were made available.Concomitant medical products: item number: 110010248, item name g7 osseoti 4 hole shell 60mm g 0mm g, lot # 6040110.Item number 01.0000.781, item name g7 10 deg arcomxl liner 36mm g, lot # 3925605.Item number 00-8775-036-01, item name biolox delta, ceramic femoral head, s, 36/-3.5, taper 12/14, lot# 2912376.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: stem does not fit.Review of event description: it was reported that patient underwent hip arthroplasty on (b)(6) 2017.During the surgery, surgeon implanted avenir stem and it sat proud several millimeters.He was unable to reduce the hip with a -3.5mm head.So, decision was made to extract stem and attempt to re-broach the femoral canal to sink the stem deeper.Stem trunnion was damaged during extraction because threaded slaphammer was not available in instrument set.After stem was removed, surgeon prepared femur for taperloc stem which was implanted without incident.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents were received.Devices analysis no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: the compatibility check was performed and showed that the product combination was approved by zimmer biomet.Inspection plan: characteristic no.63 feature "dimension" with scope of testing: 100%; means of inspection: 3d-measuring machine.Characteristic no.69 feature "dimension" with scope of testing: 100%; means of inspection: 3d-measuring machine.Characteristic no.119 feature "dimension" with scope of testing: 100%; means of inspection: visual the surgical technique for the avenir hip system (lit.No.06.02448.012 ¿ ed.2013-09) states on page 8: ¿the modular rasp serves as a test prosthesis.The trial neck is positioned onto the rasp either by hand or using the trial neck-holder.¿ this means no test stem is applied.The reported event does not state clearly whether a trial rasp or a stem has been used as a test prosthesis.Conclusion summary according to the event during the primary op avenir stem sat proud several milimeters and did not fit.The stem was not received for the investigation, therefore the event could not be confirmed.Review of the device history records for the product did not identify any deviations or anomalies related to the reported event.Possible reasons leading to the reported event include surgeon not complying to surgical technique, wrong pre-operative surgery planning and wrong handling of device due to wrong information.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 gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: AVENIR MULLER, STEM, STANDARD, UNCEMENTED, HA, 6, TAPER 12/14
• Type of Device: AVENIR MULLER STEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7147344
• MDR Text Key: 96043927
• Report Number: 0009613350-2017-01840
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PK123392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 01.06010.006
• Device Lot Number: 2870896
• Other Device ID Number: 00889024479432
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Age: 79 YR
• Patient Weight: 113