MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR T1 PPS 11X142MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 during initial surgery, the surgeon requested to open taperloc complete xr 123 femoral stem, 11x142.The inner packaging had black powder in the sterile bag with the implant.The sterile bag appears to have been perforated by movement of the stem.This implant came from the central inventory.The surgeon chose to downsize to a size 10.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Evaluation of the returned product/photographs provided confirmed there is debris inside the sterile packaging which is consistent with the appearance of the porous coating inside the sterile barrier.In addition, the sterile pouch was damaged.Sterility cannot be confirmed as the product was returned opened, and photos show product has been removed from the sterile blister.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The condition of the product when it left zimmer biomet was conforming to specification.The root cause of the reported event can be attributed to transit damage and packaging design deficiency.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.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.

Event Description

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

• Brand Name: TPRLC XR T1 PPS 11X142MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11155592
• MDR Text Key: 226303910
• Report Number: 0001825034-2021-00059
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K120030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• 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: 51-105110
• Device Lot Number: 3791139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/12/2021
• Supplement Dates Manufacturer Received: 03/02/2021
• 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