MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 TYPE1 PPS SO 9X137MM; 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 06/30/2020

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 that the nurse passed off device to the tech, who upon seeing the package, refused the implant as it had black colored substance in the packaging.The package was not opened.A new implant was opened and used.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

This follow-up report is being submitted to relay additional information.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.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The likely condition of the products when they left zimmer biomet was conforming to specification.The root cause of the reported event is likely to be due 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 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.

Event Description

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

• Brand Name: TPRLC 133 TYPE1 PPS SO 9X137MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10312826
• MDR Text Key: 200042106
• Report Number: 0001825034-2020-02895
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K101086
• 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: 09/29/2020

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: 51-103090
• Device Lot Number: 3947709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 09/28/2020
• Supplement Dates FDA Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1