MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC FEMORAL STEM; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem No Patient Involvement (2645)

Event Date 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source (b)(6).Complaint sample was returned and reviewed against the reported event.Six boxes were returned and evaluated, noting the sterile barrier has been broken on three of the boxes.The other three remain intact.Dhr was reviewed and no discrepancies were found.The likely condition of the device when it left zimmer biomet is conforming to specification.The investigation has concluded that the root cause of the reported event is likely to be damage during transit.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01297, 0001825034-2020-01299.

Event Description

It was reported that during stock investigation, it was found that the sterile packages were damaged.There was no patient involvement.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: TAPERLOC FEMORAL STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10314507
• MDR Text Key: 200429260
• Report Number: 0001825034-2020-01300
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304491881
• UDI-Public: (01)00880304491881
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• 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: 51-103150
• Device Lot Number: 3513701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• 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