MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR T1 PPS 14X148MM; PROSTHESIS HIP

Catalog Number 51-105140

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2021

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 surgeon noticed foam inside the package from the stem pouch tearing and the stem rubbing the inside of the package.The surgery was completed with a backup device.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: d4;g3; h2; h3; h4; h6 visual evaluation of the returned product/provided photo(s) identified damage to the sterile packaging pouch with debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging and the porous coating.Sterility has not been compromised.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.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported event can be attributed to transit damage.The sterile packaging configuration is moving to a double blister configuration 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 14X148MM
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11324323
• MDR Text Key: 231701551
• Report Number: 0001825034-2021-00461
• Device Sequence Number: 1
• Product Code: OQG
• Combination Product (y/n): N
• PMA/PMN Number: K1200330
• 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: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 51-105140
• Device Lot Number: 6222399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1