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

Catalog Number 11-165228

Device Problems Difficult to Insert (1316); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: taiwan.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 Description

It was reported that while assembling the cup and liner during a procedure, the two pieces did not assemble smoothly.Upon further inspection, it was determined that the c-ring inside the cup was deformed.There were not health consequences or impact to the patient.Attempts have been made and no further information is available.

Manufacturer Narrative

(b)(4).Upon visual inspection the liner had a circular indentation around the outer diameter.The shell also had scuffing on the outer diameter.The locking ring was returned with the chamfer in the correct position.The locking ring was bent and twisted.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.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 Description

No additional event information to report at this time.

• Brand Name: RINGLOC BI-POLAR 28X52MM
• Type of Device: 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: 16444473
• MDR Text Key: 310348722
• Report Number: 0001825034-2023-00396
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00880304001930
• UDI-Public: (01)00880304001930(17)270809(10)822390
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K051569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11-165228
• Device Lot Number: 822390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN LINER