MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TLOC 133 MP SP T1 PPS HO 5X95; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 11/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Report source: (b)(6).

Event Description

It was reported, when the stock was investigated debris in sterile packaging was noted.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were {updated/corrected}.B4, b5, g3, g6, h1, h2, h3, h6, h10.Complaint sample was evaluated and the reported event was confirmed.Lot #6222140 foreign debris is present inside the sterile packaging, and the sterile packaging remains sealed.In addition, debris inside the sterile packaging was found which is consistent with the appearance of the porous coating.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Investigation results concluded that the reported event was due to the condition of the product when it left zimmer biomet was non-conforming to specification.The root cause of the reported event (foreign debris) is attributed to the operator not following the work instructions provided.The root cause of the black porous coating debris can be attributed to transit damage and packaging design deficiency.This reported event (foreign debris) falls within the scope of ca-04759, the purpose of which is to address the issue of complaints for debris in sterile packaging.This capa was closed successfully in october 2019.In addition, this device falls within the scope of ca-03419 (black porous coating debris), the purpose of which is to assess all current sterile barrier systems used to package products at zimmer biomet bridgend.As part of this capa, the pouch is being improved to use a stronger material (nylon), and foam end caps are being added.Also, the orientation the devices are packed in the shipper box is moving from vertical to horizontal, and the thickness of the shipper box has been increased.

Event Description

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

• Brand Name: TLOC 133 MP SP T1 PPS HO 5X95
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10836291
• MDR Text Key: 216151864
• Report Number: 0001825034-2020-04106
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K110400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• 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: 51-109050
• Device Lot Number: 6222140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1