MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM CEMENTLESS COLLARED HIGH OFFSET 12/14 TAPER SIZE 5; PROTHESIS, HIP

Catalog Number	574202050
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product was returned and evaluated.Review of the provided pictures showed the outer blister had a crack in it.The returned product was assessed and confirmed that the corner of the outer cavity had split open and partially opened the tyvek lid.The inner cavity was found undamaged and sealed.The sterility was breached due to the outer cavity being cracked.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Medical records were not provided.The condition of the device when it left zimmer biomet control 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 provided photos and 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 plastic had crack on the packaging.It was determined that sterility had been breached due to the outer cavity of the packaging being cracked.There is no further information available at the time of this report.

• Brand Name: FEMORAL STEM CEMENTLESS COLLARED HIGH OFFSET 12/14 TAPER SIZE 5
• Common Device Name: PROTHESIS, 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: 22107632
• Report Number: 0001822565-2025-01597
• Device Sequence Number: 15512140
• Product Code: LZO
• UDI-Device Identifier: 00889024509177
• UDI-Public: (01)00889024509177(17)291014(10)3212902
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K182048
• 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
• Report Date (Section B): 05/29/2025

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: Health Professional
• Device Catalogue Number: 574202050
• Device Lot Number: 3212902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2025
• 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: 05/23/2025
• Initial Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• 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 Sex: Unknown