MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL RED LAT NC 9X125 5; PROSTHETIC, HIP

Model Number N/A

Device Problem Inaccurate Information (4051)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).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 a packaging error for echo bimetric stem, but the labelling specifies echo press-fit stem.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Review of the provided picture identified that the brand name on the label is incorrect.This complaint was confirmed by review of the provided photo.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The condition of the device when it left zimmer biomet is non-conforming to specification.The root cause of the reported event is a labeling issue with the brand name.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

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

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d9; g3; h2; h3; h6 product has been returned.Visual evaluation confirmed that the brand name on the label is incorrect.The complaint has been confirmed.The investigation remains the same as previous.No further actions are needed at this time.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: ECHO POR FMRL RED LAT NC 9X125 5
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11118324
• MDR Text Key: 225338971
• Report Number: 0001825034-2021-00012
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00887868260841
• UDI-Public: (01)00887868260841
• Combination Product (y/n): N
• PMA/PMN Number: K070274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2021

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: 192509
• Device Lot Number: 962230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 03/26/2021; 05/03/2021
• Supplement Dates FDA Received: 03/29/2021; 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1