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

Model Number	N/A
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional 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
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11118324
• Report Number: 0001825034-2021-00012
• Device Sequence Number: 14354594
• Product Code: KWA
• UDI-Device Identifier: 00887868260841
• UDI-Public: (01)00887868260841
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K070274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 03/26/2021; 05/03/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 03/29/2021; 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1