MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR T1 PPS 16X152MM MM T1; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

Upon further investigation, it has been determined that the debris is the sterile packaging meets the acceptable criteria specifications.This event is no longer considered reportable.Therefore, the initial report should be voided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D4: (b)(4).Visual evaluation of the returned products identified that there is debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier and black debris consistent with porous material from the device.Review of the device history records identified no related deviations or anomalies.These products were likely conforming when they left zimmer biomet control.The root cause of the reported issue is attributed to transit damage causing the foam packaging to become abraded and shed.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 investigation, it has been determined that the debris in the sterile packaging meets the acceptable criteria and product is conforming to specifications.Event is no longer considered reportable, and initial report should be voided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TPRLC XR T1 PPS 16X152MM MM T1
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10584487
• MDR Text Key: 208585448
• Report Number: 0001825034-2020-03625
• 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: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 51-105160
• Device Lot Number: 2867464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1