MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EPOLY 36MM RLC LNR MROM SZ24; PROSTHETIC, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 09/27/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: 13-104156 item name m/h 3hole rlc shl nrs 56mm/l24.Lot # 877600.11-363662, 36mm cocr mod hd std # 239080.51-107170 , item name tprlc 133 mp type1 pps ho 17.0.Lot # 2474144.Multiple mdr reports were filed for this event, please see associated reports 0001825034 - 2024 - 00014.0001825034 - 2024 - 00016.0001825034 - 2024 - 00017.The device will not be returned for analysis as it remains implanted; 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 remains implanted.

Event Description

It was reported that 10 months post implantation the patient reported experiencing right hip and groin pain for 6 months.The pain was affecting his ambulation and daily activities.Prescription pain medication and an assistive device along with a bone scan to further assess this was recommended.The bone scan was consistent with degenerative changes.One year later, the patient presented with some pain again however no prescription measures were recommended as treatment and resolved on it's own.There is no additional information available at this time.

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.Complaint confirmed based on the evaluation of the provided medical records review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: patient reported pain in the groin and r thigh with increased activity.Pain greater than 6 months post-op which limited the patient¿s activities and ability to ambulate as well as required prescription pain medication to resolve.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: EPOLY 36MM RLC LNR MROM SZ24
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18452371
• MDR Text Key: 332184728
• Report Number: 0001825034-2024-00015
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: EP-105994
• Device Lot Number: 738730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Other
• Patient Sex: Male
• Patient Weight: 115 KG
• Patient Race: White