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

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source (b)(6).This product is not cleared for distribution in the us, however it is similar to 510k k051569.Product is in process of being returned to zimmer biomet for the investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the sterile packaging was found to be damaged when the product was opened.It is unknown if the sterility of the product has been compromised and the product was removed from the field and a new product was used to complete the surgery.There was no direct contact with the patient.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was returned and evaluated against the reported event.Visual inspection of the returned product and provided photos found the inner sterile blister was cracked.The outer sterile blister was intact, therefore, sterility has not been breached.Dhr was reviewed and no discrepancies were found.The root cause can be attributed to transit damage.The product was likely conforming when it left zimmer biomet and is therefore considered not reportable.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 28X51MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10734270
• MDR Text Key: 213032753
• Report Number: 0001825034-2020-03892
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00880304568785
• UDI-Public: (01)00880304568785
• Combination Product (y/n): N
• PMA/PMN Number: NOT CLEARED
• 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: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2023
• Device Model Number: N/A
• Device Catalogue Number: 110010462
• Device Lot Number: 511100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1