MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL STEM CEMENTED; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D1: femoral stem cemented std.Collar 12/14 neck taper std.Neck offset size 13 130 mm stem length.G2: foreign: japan.Suggested component code: mechanical (g04) - stem.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the proximal centralizer was damaged when the outer box was opened.The surgeon only used the stem to complete the surgery.There was a one (1) to (2) minute delay.No consequences or impact to the patient.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: d9; g3; h2; h3; h6 visual examination of the returned product identified the ¿13¿ size identifier marking and angled corners of the centralizer sleeve.Sleeve is fractured in half at the size identifier marking location.Sleeve has some light scratches on outside surface.No other damage was noted during visual evaluation.No stem or packaging components/carton returned, only centralizer sleeve component was returned for evaluation.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.The reported event is confirmed, as the returned product evaluation confirmed the sleeve is broken.However, the reported out of box complaint is not confirmed as photographs/returned device packaging were not included and, transit damage cannot be ruled out.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
No further information at the time of this report.

• Brand Name: FEMORAL STEM CEMENTED
• 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: 22024532
• Report Number: 0002648920-2025-00137
• Device Sequence Number: 9114926
• Product Code: JDI
• UDI-Device Identifier: 00889024138148
• UDI-Public: (01)00889024138148(17)310106(10)64811047
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K950312
• 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,Followup
• Report Date (Section B): 07/22/2025

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00785001300
• Device Lot Number: 64811047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2021
• 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