MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR T1 PPS 15X150MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 07/30/2020

Event Type  malfunction  

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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-03318, 0001825034-2020-03319, 0001825034-2020-03320, 0001825034-2020-03321, 0001825034-2020-03322, 0001825034-2020-03323.

Event Description

It was reported the circulated items in the warehouse identified debris in sterile packages.No patients were involved.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d10; g4; h2; h3; h6 -the event reports that debris was identified inside the sterile packaging.-this was identified at a zb distribution centre, therefore there was no patient, user, or stakeholder harm.-evaluation of the returned product/photographs provided confirmed there is debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier.Sterility has not been compromised.The reported event is confirmed.-the likely condition of the product when it left zimmer biomet was conforming to specification.The root cause of the reported event is likely to be due to transit damage.-this device falls within the scope, the purpose of which is to assess all current sterile barrier systems used to package products at zimmer biomet bridgend.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.Upon reassessment of the reported event, sterility has not been compromised and was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: TPRLC XR T1 PPS 15X150MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10441976
• MDR Text Key: 204009241
• Report Number: 0001825034-2020-03321
• Device Sequence Number: 1
• Product Code: OQG
• Combination Product (y/n): N
• PMA/PMN Number: K120030
• 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: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• 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: 51-105150
• Device Lot Number: R3305275A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1