MAUDE Adverse Event Report: ZIMMER GMBH AVENIR MULLER, STEM, STANDARD, UNCEMENTED, HA, 4, TAPER 12/14; AVENIR MULLER STEM CEMENTLESS

Model Number	N/A
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer did not receive devices, x-rays, or other source documents for review as the patient has not been revised.The device history records were reviewed and found to be conforming.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.(b)(4).
Event or Problem Description
During surgery it was found that there was a size mismatch between the implants.
Event or Problem Description
Please refer to report 0009613350 - 2018 - 01252.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trigger considering the following event is identified: stem does not fit as intended.Event description: during the surgery the surgeon thought that there was an apparent difference between the avenir rasp size 4 standard cementless and the definitive prosthesis during the surgery.The definitive prosthesis couldn't be implanted as deep (at least 5mm less deep).The surgeon then implanted the original avenir shaft standard cementless with ref.01.06010.004 lot.2959947 and implanted a shorter head.In the op there was a delay of max 10 minutes.Surgeon questioned whether the shaft size given on the packaging is correct.After the op, surgeon compared the the x-ray template with with the original implant and has concluded that everything was correct and there was no discrepancy between rasp and prosthesis.For him the case is solved.Review of received data: post-op x-ray compared with x-ray template of prosthesis avenir müller stem size 4 is received.Respective measurements were done on the x-ray and it showed that the stem is a 4 size stem as was indicated.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment.Conclusion: the investigation results did not identify a non-conformance or a complaint out of box (coob).The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.After the op surgeon already indicated that there was no discrepancy between the stem and the rasp.Upon investigation, it has been confirmed that the size 4 stem implanted had the correct size.The most likely reason for the stem not being fit into the femoral canal as the surgeon aimed is the misinterpretation of the x-ray template.Based on the given information the complaint could be confirmed.However, no exact root cause could be identified.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, 4, TAPER 12/14
• Common Device Name: AVENIR MULLER STEM CEMENTLESS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8168248
• Report Number: 0009613350-2018-01252
• Device Sequence Number: 16463641
• Product Code: LZO
• UDI-Device Identifier: 00889024479517
• UDI-Public: 00889024479517
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K123392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 01.06010.004
• Device Lot Number: 2959947
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1