MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RINGLOC BI-POLAR 28X52MM; PROSTHESIS, HIP

Catalog Number	11-165228
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: associated product: pn: 802202802 item name: femoral head ln: 66990741.Pn: unknown item name: unknown shell ln: unknown.G2: foreign: canada.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the shell/locking ring and inner liner would not assemble together.Upon inspection, the inner ring looked deformed.There was no delay or impact to the patient.There is no further information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;d4;d9;g3;h2;h3;h4;h6 product was returned and evaluated.Visual examination of the returned product identified that the shell was returned with the associated head, lock ring in the shell groove, and liner disassembled.The shell showed indentation on the outer spherical surface and scratches around the damaged lock ring gap in the groove.The liner showed indentations on the outer spherical surface consistent with the lock ring from attempted assembly in the field.The lock ring was confirmed bent downward in the shell at the gap.The lock ring chamfer orientation was correctly installed.The lock ring was removed during evaluation and there were confirmed gouges from the shell on the underside.Dimensional analysis was performed on the ring for width and diameter and found to be within specification.Review of the device history record identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.A definitive root cause cannot be determined.Based on the returned product review, the complaint was 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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: RINGLOC BI-POLAR 28X52MM
• 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: 21706725
• Report Number: 0001825034-2025-00853
• Device Sequence Number: 13247288
• Product Code: JDI
• UDI-Device Identifier: 00880304001930
• UDI-Public: (01)00880304001930(17)290822(10)66744539
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 11-165228
• Device Lot Number: 66744539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Unknown