MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FEM RED LAT NC 11X135; PROTHESIS, HIPS

Model Number N/A

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/15/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).G2: foreign: new zealand.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that after a biometric stem was opened and implanted, the team noticed two (2) oral swabs inside the same container as the stem.There was no reported impact to the patient.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Proposed component code: swab.Visual examination of the provided pictures identified the swabs within the package as reported.A review of the device history records identified no related deviations or anomalies during manufacturing.A review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.The root cause of the reported issue is attributed to a manufacturing issue.The event is confirmed via the provided photo and chs.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional event information to report at this time.

• Brand Name: ECHO POR FEM RED LAT NC 11X135
• Type of Device: PROTHESIS, HIPS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17698886
• MDR Text Key: 322837802
• Report Number: 0001825034-2023-02094
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304462878
• UDI-Public: (01)00880304462878(17)250511(10)534040
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K070274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 192511
• Device Lot Number: 534040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1