MAUDE Adverse Event Report: ZIMMER GMBH AVENIR STEM HIP IMPLANT; 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 03/02/2017

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

Investigation results were made available.As for zimmer specialists to perform an in-depth analysis it is required to have all necessary information at hand, it was therefore tried several times to receive more information for this case.Additional information was received on june 1, 2017 and has been included in this report (date of event, patient's information, event description).However, no reference and lot number were provided.A technical investigation was not possible to perform, as the device was not at hand for investigation.Dhr review: as no lot numbers were provided for the devices, the device history records could not be reviewed.At zimmer (b)(4) all medical devices prior release to market undergo several quality inspections as defined in our quality procedures.Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold.These procedures are part of the overall quality management system at zimmer (b)(4) and get regularly audited by our notified body, competent authorities and internal and external auditors.Thus, for all products sold to the market can be assumed having a complete and correct dhr.Trend analysis: no trend analysis could be performed as no item number was available.Review of event description: it was reported that the avenir shaft could not be fixed during hip surgery.The following additional event description has been received: after regular cementing of the shaft and completed hardening, the change of a trial drop in head occurred through a strong hit with the plastic repositioning stem and the hammer.Hereby doubts were raised about the firmness/strength of the shaft cementing ¿ alleged movement between prosthesis and cement mantle.In order to check the firmness under axial pressure, the extractor was used.The prosthesis was removed from the hardened cement mantle without force.Subsequent cementing of a shaft, one size smaller, in the remaining cement mantle.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 correct implantation steps for the avenir müller stem is described in the surgical technique.Root cause analysis: it was reported that the avenir stem could not be implanted as an issue occurred with the cementing part.The stem was not able to be fixated in the cement mantle.Therefore, the surgeon decided to use a smaller avenir stem in the remaining cement mantle.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 lit.No.06.01340.012.However, all possible causes related to the device reported are listed in dfmea.Conclusion summary: 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.(b)(4).

Event Description

It was reported that a cemented zimmer avenir stem could not be fixed during surgery on (b)(6) 2017.The surgery was completed with another component with 20 minutes delay.

• Brand Name: AVENIR STEM HIP IMPLANT
• 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: 6435522
• MDR Text Key: 70906591
• Report Number: 0009613350-2017-00444
• 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
• 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 Model Number: N/A
• Device Catalogue Number: UNKOWN
• Device Lot Number: UNKOWN
• Other Device ID Number: UNKOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 83 YR