MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RINGLOC BI-POLAR 28X51MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Difficult To Position (1467); Device-Device Incompatibility (2919)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 during initial surgery the bipolar head could not be successfully mated with the acetabular component due to a damaged locking ring.The procedure was finished with another device.Attempts have been made and no further information has been made available at this time.

Manufacturer Narrative

The following report is submitted to relay additional information received.The complaint sample was evaluated and the complaint is confirmed.Upon visual inspection there is no damage to the inside radius of the shell.There is damage to the liner around the outside radius in the form of indentations.No further measurement taken as the liner has been impacted.The head is assembled into the liner and could not be removed for analysis.The locking ring is bent and twisted preventing it to fit properly into the groove in the shell.Dimensional measurements of the locking ring as measured found to be conforming to the device print specifications.Review of the device history records for the reported devices identified no deviations or anomalies.The most likely cause of the event is due to misalignment of the liner during the liner insertion.This is indicated by the witness marks on the o.D.Of the liner.Why the malalignment occurred is not known with the information provided.A definitive root cause cannot be provided with the information available.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 during an initial bi-polar hip arthroplasty procedure, the bipolar head and liner could not be reduced and assembled inside the metal shell.After a second failed attempt to seat, it was discovered that the locking ring was bent.The procedure was finished with another device.There were no patient consequences as a result of the malfunction.Attempts have been made and no further information has been made available.

• Brand Name: RINGLOC BI-POLAR 28X51MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7478665
• MDR Text Key: 107360326
• Report Number: 0001825034-2018-03131
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK051569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/07/2023
• Device Model Number: N/A
• Device Catalogue Number: 11-165226
• Device Lot Number: 914290
• Other Device ID Number: (01) 0 0880304 20973 2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 05/01/2018
• Supplement Dates Manufacturer Received: 06/05/2018
• Supplement Dates FDA Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 91 YR