MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. CPT FEMORAL STEM 12/14 NECK TAPER STD. OFFSET SIZE 2 130 MM STEM LENGTH; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: united kingdom.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 implant was damaged in the packaging and the plastic seal was ripped.The device is no longer sterile.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: g3, g6, h2, h3, h6.The product has been confirmed to exhibit outer packaging and/or labeling damage that did not result in a loss of sterility or label legibility.This complaint has been confirmed by review of the provided photo(s) and/or returned product.The reported event did not occur in an operating room or as part of a medical procedure.Based on the damage observed on the product, the damage to the outer packaging and/or labeling is consistent with damage from transit; therefore, the root cause of the reported event is attributed to transit damage.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.
Event or Problem Description
No additional event information to report at this time.

• Brand Name: CPT FEMORAL STEM 12/14 NECK TAPER STD. OFFSET SIZE 2 130 MM STEM LENGTH
• Common Device Name: PROSTHESIS, HIPS
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18897186
• Report Number: 0002648920-2024-00063
• Device Sequence Number: 6248318
• Product Code: JDI
• UDI-Device Identifier: 00889024145771
• UDI-Public: (01)00889024145771(17)330723(10)66054256
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K191735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2024

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: 00811400200
• Device Lot Number: 66054256
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• 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
• 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
• Patient Sex: Prefer Not To Disclose