MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL RED NC 16X160MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 06/22/2019

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 that upon opening the femoral stem's inner sterile container the plastic rim was torn.No impact or consequences to patient have been reported.No additional information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon receiving the device, it was determined the sterility was not compromised, and it was determined to be not reportable.The initial report was forwarded in error and should be voided.

Event Description

Upon receiving the device, it was determined the sterility was not compromised, and it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: ECHO POR FMRL RED NC 16X160MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8813687
• MDR Text Key: 151794148
• Report Number: 0001825034-2019-03147
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K070274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 192416
• Device Lot Number: 821910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 88 YR