MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 RINGLOC BIPOLAR 28X44MM; 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 06/03/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products.E1 liner.Report.Source: foreign country: japan.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the locking ring was bent.The e1 liner could not be placed in the outer shell while using the e1 bipolar cup.It is unclear whether the ring was originally deformed or was deformed when the liner was inserted.The surgery was completed with a second device.No patient consequences were reported as a result of the malfunction.Additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Device was returned and evaluated.Upon visual inspection the liner had indentations on the outer diameter.The locking ring was installed in the shell with the chamfer in the correct position upon return.The ring was removed and evaluated for the bend with scuffing to the underside.Medical records were not provided.A review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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.

• Brand Name: E1 RINGLOC BIPOLAR 28X44MM
• 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: 15100121
• MDR Text Key: 301259803
• Report Number: 0001825034-2022-01709
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304568778
• UDI-Public: (01)00880304568778(17)270429(10)915010
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NI
• 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: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• 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: 110010461
• Device Lot Number: 915010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2022
• 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