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

Model Number N/A

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

Patient Problems Fall (1848); Pain (1994)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device remains implanted and will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-03480 0001822565-2023-03466 0001822565-2023-03476.

Event Description

It was reported that approximately nine years post implantation of a right total hip arthroplasty, the patient received a cortisone shot due to pain.It was reported that the initial pain came from a stretching exercise, and the pain was both weight bearing and non-weight bearing.The patient had also sustained three falls within a six-month period.There was no information available related to how the falls occurred.The surgeon determined that the patient had a right hip strain and was treated with a cortisone injection in the right hip bursa.No further complications have been reported.No additional information is available.

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.A review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.A review of the available records identified the following: an initial right total hip arthroscopy was performed, and approximately nine years later, the patient reported three falls in six months with pain.Cortisone injections were provided; however, the pain persisted.Radiographs were also provided and reviewed by a health care professional.A review of the available records identified the following: anatomic alignment of the right hip arthroplasty.It was reported the patient fell multiple times and began experiencing pain.As the reason for the falls were unknown, a definitive root cause cannot be identified.The reported issue was confirmed based on the provided medical records.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

No further event information is available at the time of this report.

• Brand Name: EPOLY 36MM RLC LNR MROM SZ24
• Type of Device: HIP, PROTHESIS
• 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: 18282698
• MDR Text Key: 329941246
• Report Number: 0001822565-2023-03474
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: N/A
• Device Catalogue Number: EP-105994
• Device Lot Number: 935230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2011
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Race: White