MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 RINGLOC BIPOLAR 28X51MM; PROSTHEIS HIP

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).This product is not cleared for distribution in the u.S.However, this report is being submitted as a similar device is cleared for distribution under 510k number k921181.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 when the sterile packaging of this product was opened, ring of bipolar cup had come off and bent.This surgery was finished with backup product.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

The event is confirmed with product returned.Upon visual inspection the locking ring had been removed from the shell.No debris could be seen inside of the locking feature of the shell.The bend in the locking ring is away from the chamfer and the scratches to the underside of the locking ring correspond with impaction.Dhr was reviewed and no discrepancies relevant to the reported event were found.A corrective action has been initiated to determine the root cause.

Event Description

No further event information available at the time of this report.

• Brand Name: E1 RINGLOC BIPOLAR 28X51MM
• Type of Device: PROSTHEIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8705024
• MDR Text Key: 148204987
• Report Number: 0001825034-2019-02589
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2022
• Device Model Number: N/A
• Device Catalogue Number: 110010462
• Device Lot Number: 988520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1