MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL NC 13X145MM; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a hip hemiarthroplasty utilizing the echo bi-metric collarless, press fit stem.The surgeon broached and canal reamed to the appropriate fit for trialing (size 13 broach) and trialed successfully.The matching echo-biometric implant (size 13, std offset) was opened to be implanted in the patient.When the surgeon attempted to implant the hip stem, it was discovered the implant was at least two sizes too small compared to the matching size broach that was used for trialing.All broaches and canal reamers used were double checked and no discrepancies or mistakes in our technique were found.The surgeon was able to subside the stem past the calcar by hand with little to no resistance, suggesting the implant was at least two sizes too small.The surgeon proceeded to broach, and canal ream up to a size 14 and after much work successfully implanted a size 14 echo-biometric stem.It appears the size 13 implant attempted for use was mislabeled and a few sizes smaller than it was supposed to be.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: d4, g3, g6, h2, h3, h6.Suggested component code: mechanical (g04) ¿ stem.Visual examination of the provided pictures identified the full stem and etching without damage noted.No further evaluation can be made.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.This complaint cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ECHO POR FMRL NC 13X145MM
• Common Device Name: PROSTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20588845
• Report Number: 0001825034-2024-02576
• Device Sequence Number: 6558854
• Product Code: KWA
• UDI-Device Identifier: 00887868260742
• UDI-Public: (01)00887868260742(17)340317(10)66510314
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K070274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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 Model Number: N/A
• Device Catalogue Number: 192413
• Device Lot Number: 66510314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Sex: Male