MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EPOLY RLC 36MM 10DEG SZ24; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a right total hip arthroplasty on an unknown date, and a right hip revision approximately three years ago due to recurrent dislocations.Subsequently, the patient was revised a second time approximately one month ago due to recurrent dislocations.No additional information available.
Additional Manufacturer Narrative
(b)(4).A2: date of birth: information provided by the hospital showed the date of birth documented as two different dates: (b)(6) 1947 and (b)(6) 1948.D10: cat# unknown lot# unknown-unknown zimmer biomet unk 4-finned acetabular shell.Cat# unknown lot# unknown-unknown zimmer biomet stem.Cat# 105424 lot# 655270 rnglc locking ring sz 24.Cat# 11-363663 lot# 614570 36mm cocr mod hd +3mm.G2: foreign: country: australia.Product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;g3;h2;h3;h6.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.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.However, since the stem and shell are unknown, it is unknown if the entire construct is compatible.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right hip arthroplasty dislocation.Medical records timeline: hip revision preformed due to recurrent dislocations.Subsequently the patient was revised on approximately three years later for recurrent dislocations.A definitive root cause cannot be determined.The complaint was confirmed based on the x-ray results.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-01025.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: EPOLY RLC 36MM 10DEG SZ24
• Common Device Name: PROTHESIS, 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: 19109137
• Report Number: 0001825034-2024-01026
• Device Sequence Number: 7766409
• Product Code: JDI
• UDI-Device Identifier: 00880304455245
• UDI-Public: (01)00880304455245(17)231221(10)214770
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K070399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/21/2023
• Device Model Number: N/A
• Device Catalogue Number: EP-105894
• Device Lot Number: 214770
• 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: 04/08/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2018
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female