MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT; PROSTHESIS HIP

Catalog Number 00771100440

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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 ml taper stem was protruding out of plastic sterile tray inside of the box.The outside box itself was not damaged.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.The following sections were updated/corrected updated: d4 expiration date and udi number; g3; h2; h3; h6 visual examination of the returned product found the stem has punctured through the sterile pouch and sterile inner blister.Sterility has been breached.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded the most likely root cause of the event can be attributed to transit damage.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: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11787751
• MDR Text Key: 249805616
• Report Number: 0001822565-2021-01208
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 00889024131613
• UDI-Public: (01)00889024131613(17)150122(10)62925409
• Combination Product (y/n): N
• PMA/PMN Number: K192660
• 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: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00771100440
• Device Lot Number: 62925409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1