MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO BI-METRIC MICROPLASTY HIP SYSTEM MP FP SO 13; PROSTHESIS, HIP

Catalog Number	193013
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial hip procedure.During the procedure, the surgeon broached to a size 13 femoral stem; however, when placing the final stem, the surgeon noted that there was not enough bone support surrounding the uncemented stem, and the fit of the implant was inadequate.The stem was removed.The procedure was completed with a new stem.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: d4; g3; h2; h3; h4; h6.Proposed code: mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records/operative reports were provided and identified the following: the patient had an initial right tha.During the procedure, surgeon broached femoral canal however there was not much support of the cancellous bone around the stem.There was a change in pitch with impacting the broach as well as no further sinking of the broach.A stem was placed, but noted the stem was more anteversion than the broach and was countersinking.The fit and fill was not optimal due the suboptimal bone quality.Surgeon broached to a bigger size; however it was noted there was inadequate stability.The decision was made to convert to a cemented stem.Leg length and stability was satisfactory.A definitive root cause cannot be determined.Based on the medical records provided, the complaint is confirmed.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.

• Brand Name: ECHO BI-METRIC MICROPLASTY HIP SYSTEM MP FP SO 13
• Common Device Name: PROSTHESIS, HIP
• 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: 21229914
• Report Number: 0001825034-2025-00197
• Device Sequence Number: 8284994
• Product Code: LPH
• UDI-Device Identifier: 00880304697805
• UDI-Public: (01)00880304697805(17)291014(10)704890
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K143009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

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
• Device Catalogue Number: 193013
• Device Lot Number: 704890
• 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: 01/14/2025
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2019
• 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 Sex: Female