MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 0 105 MM STEM LENGTH; PROSTHESIS, HIP

Model Number N/A

Device Problems Unstable (1667); Malposition of Device (2616); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 04/26/2023

Event Type  Injury  

Event Description

It was reported the patient underwent a hip procedure.Subsequently, the patient was revised approximately 1 year later due to instability, malposition, and loosening.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Proposed component code: mechanical (g04)-stem.D10: cat# 802202803.Lot# 3047454.Zimmer biomet¿ cocr head femoral head 12/14 taper 28mm diameter +3.5mm neck.Length cocrmo.G2: foreign: australia.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right total hip arthroplasty with possible early loosening at the bone cement interface of the femoral stem also with valgus positioning.Cement plug is obliquely oriented within the medullary space of the proximal femoral diaphysis.It was noted the bone plug appeared to be incorrectly seated, however as there are many contributing factors that could have led to this and ultimately the loosened stem, a definitive root cause cannot be determined.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.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 0 105 MM STEM LENGTH
• Type of Device: PROSTHESIS, 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: 17798110
• MDR Text Key: 324026373
• Report Number: 0002648920-2023-00229
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K200823
• 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
• Report Date: 09/20/2023

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00811400010
• Device Lot Number: 64768862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2020
• 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): Hospitalization; Required Intervention
• Patient Sex: Male