MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 7 years and 5 months post implantation the patient underwent a revision procedure due to unknown reasons.The femoral head and stem were both revised.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10: 00811400110 item name femoral stem 12/14 neck taper ext.Offset size 1 130 mm stem length lot # 63322613.G2: foreign: australia.Multiple mdr reports were filed for this event, please see associated reports 0002648920 - 2024 - 00086.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted h3 other text : device location is unknown.
Event or Problem Description
Upon reassessment of the reported event and additional information received, the head was determined to be not reportable as it was confirmed that the patient had a peri-prosthetic fracture of the femur due to post operative trauma.The initial report was forwarded in error and should be voided.
Additional Manufacturer Narrative
Upon reassessment of the reported event, the head was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
• Common Device Name: PROSTHETIC, 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: 18958220
• Report Number: 0002648920-2024-00085
• Device Sequence Number: 21193615
• Product Code: LPH
• UDI-Device Identifier: 00889024144682
• UDI-Public: (01)00889024144682(17)260531(10)63377762
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• 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): 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 00801803203
• Device Lot Number: 63377762
• Was Device Available for Evaluation?: No
• 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: 03/02/2024
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2016
• 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: Unknown
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose