MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AVENIR COMPLETE FEMORAL STEM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product is in process of being returned to zimmer biomet for the investigation and a follow-up mdr will be submitted upon completion.
Event or Problem Description
It was reported that during an initial total hip arthroplasty, the surgeon broached the femur with a size 6.5 partially and attempted to insert a size 6 stem.The stem was loose so it was removed and the surgeon attempted to broach again with the size 6.5.The surgeon then attempted to insert a size 6.5 stem and it sat lower than the broach.The surgeon is questioning if the stems are within spec of the hybrid broach.There was no reported harm or injury to that patient.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d10; g4; h2; h3; h6 corrected: h6 h6: remove method code 4114: device not returned complaint sample was returned and evaluated against the reported event.Visual evaluation identified the following : there was damage on the neck below the conical taper.The blue discoloration is from a blue marker that bled through the autoclave bag during the decontamination process.The length of the stem was measured and was found to be conforming to specifications.No other issues were identified and no further evaluation could be performed with the returned device.Dhr was reviewed and no discrepancies were found.Was reported that a size 6.5 broach was used and a size 6 stem was tried to be implanted.This would be considered off label usage.Per the avenir complete surgical technique, "the definitive implant must correspond to the last rasp used".Therefore, the inability to seat the size 6 stem after broaching to size 6.5 can be attributed to user error.However, the root cause for not being able to seat the sz 6.5 stem is unknown.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information provided by the customer.The dhr was reviewed and no discrepancies were found.The root cause is unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-03541.

• Brand Name: AVENIR COMPLETE FEMORAL STEM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10206414
• Report Number: 0001822565-2020-02285
• Device Sequence Number: 2134150
• Product Code: LZO
• UDI-Device Identifier: 00889024509054
• UDI-Public: (01)00889024509054
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K182048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2020

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: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 574201060
• Device Lot Number: 2965855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 09/14/2020; 09/30/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 09/15/2020; 10/01/2020
• 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