MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. VERSYS FEMORAL STEM CEMENTED REVISION/CALCAR 12/14 NECK TAPER; PROTHESIS, HIP

Catalog Number	00787101562
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	01/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: country: canada.Product was returned and evaluated.Visual evaluation of the provided photo identified damage to the sterile packaging.Additional evaluation of the returned product found the stem has punctured through all sterile barriers.Sterility was considered breached.The stem had also punctured the outer carton.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 when the implant was opened, it was noted that the inner package was perforated.It was determined that the sterility had been compromised.The procedure was completed using another device.No further event information is available at this time.

• Brand Name: VERSYS FEMORAL STEM CEMENTED REVISION/CALCAR 12/14 NECK TAPER
• Common Device Name: PROTHESIS, HIP
• 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: 22124704
• Report Number: 0002648920-2025-00148
• Device Sequence Number: 7292326
• Product Code: JDI
• UDI-Device Identifier: 00889024140080
• UDI-Public: (01)00889024140080(17)330210(10)65800669
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K210842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2025

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: 00787101562
• Device Lot Number: 65800669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2025
• 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: 01/20/2025
• Initial Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown