MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EPOLY 36MM RLC LNR MROM SZ25; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Bacterial Infection (1735); Fall (1848); Bone Fracture(s) (1870); Hemorrhage/Bleeding (1888); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Muscle/Tendon Damage (4532); Insufficient Information (4580)

Event Date 07/22/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00592, 0001825034-2024-00594.D10: cat#: 650-1065, lot#: 835650 cer option type 1 tpr sleve -3.Cat#: 650-1057, lot#: 620880 cer bioloxd option hd 36mm.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial hip procedure.Subsequently, the patient was revised approximately 7 years later for unknown reasons.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: a1; a4; a5; b3; b5; b6; b7; d4; d6b; d10; e1; g3; h2; h4; h6.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2024 - 00592, 0001825034 - 2024 - 00594, 0001825034 - 2024 - 00776, 0001825034 - 2024 - 00777.

Event Description

It was reported that a patient had an initial left total hip arthroplasty.Approximately 14 years later the patient had a chronic trochanteric avulsion fracture and developed pain, stiffness, range of motion issues, and a fall that led to ongoing diagnostic tests with suspicion of alval.The patient underwent a revision due to infection.During the procedure, a small fracture of the anterior cortex occurred from the wedging of the osteotome.All implants were removed, and a competitor cement spacer was implanted.Attempts have been made and no further information has been provided.

• Brand Name: EPOLY 36MM RLC LNR MROM SZ25
• Type of Device: PROSTHESIS, 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: 18813076
• MDR Text Key: 336616884
• Report Number: 0001825034-2024-00593
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00880304457461
• UDI-Public: (01)00880304457461(17)200610(10)346300
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2020
• Device Model Number: N/A
• Device Catalogue Number: EP-105995
• Device Lot Number: 346300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2015
• 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): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Ethnicity: Non Hispanic