MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FEM RED LAT NC 17X165; PROSTHESIS, HIP

Model Number N/A

Device Problem Inaccurate Information (4051)

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

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 the part number on the label 192517 is for an echo bi-metric reduced proximal profile 17 x 165 mm femoral stem.The description on the label is for an echo fx lateralized 17 mm stem, which should be part number 12-151417.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g4; h2; h3; h6.Visual evaluation of the returned product identified that the product branding on the label is echo fx hip system however, the product is from echo bi-metric hip system.The complaint has been confirmed by visual evaluation.Review of the device history records identified no related deviations or anomalies during manufacturing.The product was likely non-conforming when it left zimmer biomet control.The root cause of the reported event can be attributed to an incorrectly approved label.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.

• Brand Name: ECHO POR FEM RED LAT NC 17X165
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10460582
• MDR Text Key: 204573090
• Report Number: 0001825034-2020-03353
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00887868260926
• UDI-Public: (01)00887868260926
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

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: 192517
• Device Lot Number: 391660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 10/29/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1