MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RINGLOC BIPOLAR VIVACT 28X45MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Twisted/Bent (2981)

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

Event Date 05/02/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).G2: japan.The reported event was confirmed by examination of the returned device.Visual examination identified that the ring was bent.However, the ring rotates freely within the locking groove and the chamfer is properly oriented facing backwards.The ring was removed from the cup during evaluation and no other damage or defects were observed.It is unknown if the damage occurred during or prior to assembly.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause could not 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

It was reported that during an initial hip arthroplasty, the surgeon was attempting to assemble the shell and liner construct when they noticed that the locking ring had bent, and the liner would subsequently not fit into the shell.The surgeon is unsure if the ring was bent prior to or during assembly attempts.The surgeon decided to use a different sized construct and surgery was completed with only a minor delay of approximately 15 minutes.There was no harm to the patient.Attempts for additional information were made and none is available.

• Brand Name: RINGLOC BIPOLAR VIVACT 28X45MM
• 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: 17439131
• MDR Text Key: 320205924
• Report Number: 0001825034-2023-01794
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/01/2023

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: 110024603
• Device Lot Number: 65783445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2022
• 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
• Patient Sex: Prefer Not To Disclose