MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 3 130 MM STEM LENGTH; PROTHESIS, HIP

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 02/07/2023

Event Type  Injury  

Event Description

It was reported the patient underwent a left hip revision four months post implantation due a femur fracture after a fall.

Manufacturer Narrative

(b)(4).Concomitant medical products: 00801803603 femoral head sterile product do not resterilize 12/14 taper 64542135.010000936 g7 hi-wall e1 liner 36mm f 7113477.110010245 g7 osseoti 4 hole shell 54mm f 7242288.Report source foreign: australia.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 Description

It was further reported that when the patient fell and fractured the femur, it caused loosening.No further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Component code: mechanical (g04)- stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.It was noted the femur fractured after a fall.However, as the reason for the fall is unknown, a definitive root cause cannot be determined.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.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 3 130 MM STEM LENGTH
• Type of Device: 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: 16488115
• MDR Text Key: 310724110
• Report Number: 0002648920-2023-00036
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00889024145825
• UDI-Public: (01)00889024145825(17)320625(10)65473619
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K191735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00811400310
• Device Lot Number: 65473619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2023
• Initial Date FDA Received: 03/06/2023
• Supplement Dates Manufacturer Received: 03/13/2023
• Supplement Dates FDA Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 103 KG