MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RINGLOC BI-POLAR 28X52MM; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Catalog Number	11-165228
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/20/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).D10: cat# 650-0327 lot# unk tprloc cocr cmtd stm t1 12.5mm cat# 650-1158 lot# unk delta cer fem hd 28/0mm 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 the patient died approximately three weeks after a hemiarthroplasty due to unknown reasons.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: b7; d4; e1; e2; e3; g2; g3; h2.D10: d10: cat# 650-0327 lot# 7187144 tprloc cocr cmtd stm t1 12.5mm.Cat# 650-1158 lot# 668200 delta cer fem hd 28/0mm t1.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: d4; g3; h2.
Event or Problem Description
No further information at the time of this report.

• Brand Name: RINGLOC BI-POLAR 28X52MM
• Common Device Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
• 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: 24525010
• Report Number: 0001825034-2026-00510
• Device Sequence Number: 21272018
• Product Code: JDI
• UDI-Device Identifier: 00880304001930
• UDI-Public: (01)00880304001930(17)260528(10)668200
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/17/2026

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 Expiration Date: 05/28/2026
• Device Catalogue Number: 11-165228
• Device Lot Number: 668200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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: 03/06/2026; 03/11/2026; 08/13/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 03/10/2026; 03/11/2026; 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2021
• 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: 83 YR
• Patient Sex: Male
• Patient Weight: 156 LB