MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER M/L FEMORAL STEM 12/14 NECK TAPER CEMENTLESS SIZE 17.5 EXTENDED OFFSET; PROSTHESIS, HIP

Catalog Number	00771101720
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual evaluation of the returned product found the sterile packaging and outer carton exhibit damage visually consistent with transit damage.The bottom panel of the carton has a pressure crease along the entire panel.Additionally, the stem has punctured the foil pouch and both sterile blisters are cracked.Sterility has been breached.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.The condition of the device when it left zimmer biomet is considered conforming to specification.The root cause of the reported event can be attributed to transit damage.This complaint was confirmed by evaluation of the returned product.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
It was reported that the nurse opened the stem, and the sterile packaging was damaged.There was no known impact or consequences to the patient.Attempts have been made, and no further information has been provided.

• Brand Name: ZIMMER M/L FEMORAL STEM 12/14 NECK TAPER CEMENTLESS SIZE 17.5 EXTENDED OFFSET
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21357504
• Report Number: 0001822565-2025-00318
• Device Sequence Number: 8482122
• Product Code: LZO
• UDI-Device Identifier: 00889024131972
• UDI-Public: (01)00889024131972(17)281231(10)64151687
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K192660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2025

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: 00771101720
• Device Lot Number: 64151687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2024
• 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: 10/17/2024
• Initial Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2018
• 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: Male