MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL HEAD 12/14 TAPER 32 MM DIAMETER +0 MM NECK LENGTH; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Bacterial Infection (1735); Tissue Breakdown (2681); Subluxation (4525)
Date of Event	10/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: (b)(6) item name 32mm i.D.Size g high wall liner lot # 65257153.(b)(6) item name femoral stem cementless collarless standard offset 12/14 taper size 2 lot / software release # 3158218.(b)(6) item name: g7 osseoti 4 hole shell 58mm g lot 66526631 g2: foreign: norway.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 patient underwent a revision procedure 19 days post implantation due to an infection and subluxation of the head and liner.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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.Medical records were provided.Medical timeline was created; patient had an initial tha.Patient was revised due to positive culture for enterococcus faecialis proteus mirabilis.During the revision, necrotic and infected tissue was removed around the stem.It was also noted the head would dislocate backwards and upwards on the edge of the liner, and likely subluxations had occurred.Due to the high risk of dislocations, the liner and head was removed and new liner and head placed.No other complications noted.A definitive root cause cannot be determined.Based on the medical record/timeline, the complaint is confirmed.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 the patient underwent a revision procedure 19 days post implantation due to an infection and subluxation of the head and liner.Patient was noted to have a positive culture for enterococcus faecalis proteus mirabilis.Patient was given dicloxacillin by mouth for approximately 3 months.It was noted during the revision procedure, the surgeon noted necrotic infected tissue.There is no additional information at the time of this report.

• Brand Name: FEMORAL HEAD 12/14 TAPER 32 MM DIAMETER +0 MM NECK LENGTH
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20824794
• Report Number: 0001822565-2024-03778
• Device Sequence Number: 8843789
• Product Code: LPH
• UDI-Device Identifier: 00889024498839
• UDI-Public: (01)00889024498839(17)340209(10)3192199
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K183457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 02/27/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 802203202
• Device Lot Number: 3192199
• 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: 11/19/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male