MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEM HEAD 28MMDIA MED NECK; PROSTHETIC, HIP

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 10/16/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision procedure for unknown reasons.No additional information has been provided at this time.

Manufacturer Narrative

(b)(4).D10: 00612005828 item name liner 28 mm i.D.For use with 58 mm o.D.Shell 20 deg.Elevated rim lot # 40251808.32-8333-055-00 item name cpt centralizer pmma pkgd lot # 54786900.00-6200-058-22 item name f/m acet shell 58mmod cluster lot # 15234700.G2: foreign: australia.Multiple mdr reports were filed for this event, please see associated reports 0001822565 - 2023 - 03100.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 Description

It was reported that the patient underwent a revision procedure post implantation due to pain and eccentric wear.The head and liner were replaced.There is no additional information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: b4.G3.G6.H2.H6 proposed component code: mechanical (g04)- head.H10.Visual examination of the provided pictures identified wear to the inner and outer rim of the liner.No damage was noted to the outer spherical surface of the head.No further evaluation can be made from the provided pictures.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.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.

Event Description

There is no update to the prior event description provided.

• Brand Name: FEM HEAD 28MMDIA MED NECK
• Type of Device: 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: 18092785
• MDR Text Key: 327636250
• Report Number: 0001822565-2023-03099
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NI
• 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,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2000
• Device Model Number: N/A
• Device Catalogue Number: 00903002900
• Device Lot Number: 21757510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/1995
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PLEASE SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 41 YR
• Patient Sex: Male