MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RINGLOC BI-POLAR HIP SYSTEM; PROSTHESIS, HIP

Catalog Number	11-165218
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	02/14/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).D10: cat# 650-0332 lot# unk taperloc lat cocr 10mm t1.G2: foreign - event occurred in netherlands.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that approximately one day post right hip implantation, the patient passed away following a cardiac arrest and resuscitation.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b5; b7; d4 lot; d10; g2; g3; h2.The following sections were corrected: e1 contact; e2; e3.D10: cat# 650-0332 lot# 7260478 taperloc lat cocr 10mm t1.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 approximately one day post right hip implantation, the patient passed away following a cardiac arrest and resuscitation.The patient cause of death was multi-organ failure.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
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; h2; h4; h6; h10.The following sections were corrected: h6 component code.Review of the reported event by a health care professional found: patients are assessed prior to surgery to detect any risks for cardiac complications; however, at times even with a complete work up, a patient may develop chest pain, ekg changes, and cardiac ischemia perioperatively.The stress of surgery can lead to myocardial ischemia or infarction via multiple mechanisms including coronary artery plaque rupture and myocardial demand ischemia.This leads to cardiac dysfunction caused by insufficient blood flow to the coronary arteries and may even lead to cardiac arrest.This at times may be masked due to anesthesia.This is a procedural related complication due to the stress of surgery and not related to a device.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The root cause of the reported event was determined to be unrelated to the device.Complaint is not confirmed.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: RINGLOC BI-POLAR HIP SYSTEM
• 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: 24662330
• Report Number: 0001825034-2026-00681
• Device Sequence Number: 9289472
• Product Code: JDI
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K051569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/13/2026

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: Lay User/Patient
• Device Catalogue Number: 11-165218
• Device Lot Number: 564480
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 04/14/2026; 06/18/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 05/11/2026; 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2022
• 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: Death
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 121 LB