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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Fall (1848); Bone Fracture(s) (1870); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Muscle/Tendon Damage (4532); Insufficient Information (4580)
Date of Event	07/22/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).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 related deviations or anomalies during manufacturing.Medical records/radiographs were provided.Review identified the following: chronic hip pain, trochanteric avulsion, stiffness, extensive osteolysis, needed to use cane, bone fracture from wedging the osteotome, acute blood loss.A definitive root cause cannot be determined.Event is confirmed via 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.

• Brand Name: EPOLY 36MM RLC LNR MROM SZ25
• Common Device Name: 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
• Report Number: 0001825034-2024-00593
• Device Sequence Number: 4324574
• Product Code: OIY
• UDI-Device Identifier: 00880304457461
• UDI-Public: (01)00880304457461(17)200610(10)346300
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K100048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2024

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/05/2024; 06/17/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 03/29/2024; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2015
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Ethnicity: Non Hispanic