MAUDE Adverse Event Report: ZIMMER GMBH AVENIR STEM, STANDARD, CEMENTED, 2, TAPER 12/14; AVENIR CEMENTED HIP STEM

Model Number N/A

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2017

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review.As no lot numbers were provided for the devices, the device history records could not be reviewed.  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.Additional information has been requested and is currently not available.(b)(4).

Event Description

It was reported that a cemented avenir stem could not be fixed on an unknown date.

Manufacturer Narrative

Where lot numbers were received for the device, the device history records were reviewed and found to be conforming.As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

It was now reported that an avenir stem, standard, cemented, 2, taper 12/14 could not be fixed during surgery on (b)(6) 2017.It was further reported that the shaft was removed from the head of the cement mantle during the surgery.The surgeon was able to complete the surgery with another device of the same size.

Manufacturer Narrative

Investigation results were made available.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: during the trend analysis no trend was identified.Review of event description: it was reported that the cemented avenir stem could not be fixed into the cement mantle and was removed.The surgery was on (b)(6) 2017.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: the correct implantation steps for the avenir müller stem are described in the surgical technique lot no:.06.01340.012.Root cause analysis: root cause determination using dfmea: failure of connection between stem and ball head due to fretting corrosion -> wear => not possible: this was a cementing issue.Failure of stem due to mechanical properties of the material (wrong material) => not possible: a systematic issue with design and/or material properties would have been detected as part of a trend review defined in complaint registration systematic assessment defined in complaint investigation or in the current pms process post market surveillance.Failure of connection between stem and ball head due to wear between taper and ball head due to bone particles (third body wear) or unclean surface of the taper => not possible: this was a cementing issue.Failure of connection between stem and ball head due to corrosion due to wrong material combination => not possible: a systematic issue with design and/or material properties would have been detected as part of a trend review defined in complaint registration , systematic assessment defined in complaint investigation or in the current pms process post market surveillance.Failure of connection between stem and ball head due to fracture of ceramic head due to unclean cone surface.=> not possible: no fracture was reported.Failure of connection between stem and ball head due to improper connection of stem and head taper during surgery => possible: it can be possible that the correct steps in the surgical technique were not followed.Damage of the components due to high load due to excessive impaction force => possible: it can be possible that the user damaged the components during the surgery.Malfunctioning of the device due to wrong handling of device due to wrong information => not possible: this was a cementing issue.There are some possible causes for insufficient cementing of avenir stems: wrong handling of cement (during mixing/ preparation).-> correct handling is described in package inserts of the cement system applied rasped femoral shaft/ cavity not cleaned and dried prior to inserting the cement.¿when using a cemented stem, clean and dry the femoral shaft using a high-pressure pulse lavage system in order to remove blood, fat and debris from the cancellous surface of the canal.¿ no cement plug inserted (cement flows too far into the bone).¿insert an appropriate distal femoral plug.¿ not enough pressure applied during cement and/ or stem insertion.Application of force on inserted stem (e.G.Impaction of head) before cement has hardened/ polymerized.¿apply the proximal seal and pressurize the cement to improve the interlock of the bone-cement interface.Insert the stem down the center, maintaining pressure on the stem through the inserter handle until the cement is polymerized.¿ inadequate cement mantle (too thick/ too thin/ not persistent).¿when using a line-to-line broaching technique, the final rasp size should match the final implant size for both cementless and cemented versions.¿ conclusion summary: it was reported that the avenir stem could not be implanted during the surgery.The stem could not be fixed into the cement mantle and was removed.Neither intra-operative x-rays nor devices or photos of the implant were received; therefore the condition of the components is unknown.The correct implantation steps for the avenir müller stem is described in the surgical technique lot.No.06.01340.012.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.Zimmer gmbh considers this case as closed.Zimmer's reference number of this file is (b)(4).

• Brand Name: AVENIR STEM, STANDARD, CEMENTED, 2, TAPER 12/14
• Type of Device: AVENIR CEMENTED HIP STEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6435637
• MDR Text Key: 70904000
• Report Number: 0009613350-2017-00441
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 01.06010.202
• Device Lot Number: 2882796
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR