MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RINGLOC BIPOLAR VIT E 28X42MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Material Twisted/Bent (2981)

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

Event Date 06/23/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown ve bipolar liner.Report source: foreign country: japan.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 the locking ring was found bent.The bipolar liner could not be placed in the outer shell while using the bipolar cup.It is unclear whether the ring was originally deformed or was deformed when the liner was inserted.A second device was used to complete the surgery.No adverse events have been reported as a result of this malfunction.Additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d9, g3, g6, h2, h3, h4, h6, h10 visual examination of the returned product identified the returned liner has indentations on the outside radius.The locking ring was returned inside of the shell with the chamfer in the correct position.Upon removal of the locking ring it had been bent.The width and thickness of the locking ring was evaluated.Both were found within conformance of the print.Device history record was reviewed and no discrepancies relevant 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 further event information available at the time of this report.

• Brand Name: RINGLOC BIPOLAR VIT E 28X42MM
• 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: 15180740
• MDR Text Key: 305147076
• Report Number: 0001825034-2022-01748
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00887868418679
• UDI-Public: (01)00887868418679(17)251027(10)64913823
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K915132
• 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: 08/29/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 30302842
• Device Lot Number: 64913823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 08/07/2022
• Supplement Dates Manufacturer Received: 08/25/2022
• Supplement Dates FDA Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1