MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR T1 PPS 17X154MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Evaluation of the returned product/photographs provided confirmed the sterile packaging blister is damaged.Sterility has not been compromised.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event can be attributed to transit damage.This reported event falls within the scope of a previous corrective action, the purpose of which is to assess all current sterile barrier systems used to package products at zimmer biomet bridgend.As part of this, 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 further investigation, it has been determined that the packaging meets the acceptable criteria specifications and the sterility has not been breached.This event is no longer considered reportable.Therefore, the initial report should be voided.

Event Description

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

• Brand Name: TPRLC XR T1 PPS 17X154MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11088064
• MDR Text Key: 224248962
• Report Number: 0001825034-2020-04441
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00880304517189
• UDI-Public: (01)00880304517189
• Combination Product (y/n): N
• PMA/PMN Number: K12003
• 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: 03/04/2021

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 51-105170
• Device Lot Number: 6114624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 03/03/2021
• Supplement Dates FDA Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1