MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPER EXT OFFSET RED NECK 5; PROSTHESIS HIP

Model Number N/A

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

Patient Problem No Information (3190)

Event Date 09/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will be returned to zimmer biomet for investigation.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 distal end of the stem had punctured through the inside plastic sterile container.Causing the sterility to be compromised.Attempts have been made and additional information on the reported event is unavailable at this time.No further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  complaint sample was evaluated and the reported event was not confirmed.The reported device was returned for evaluation.Visual inspection of the box found the inner cavity had a puncture.Only the carton inner cavity and ifu were returned.The outer cavity wasn¿t returned.The outer carton box was damaged on one flap.Device history record was reviewed and no discrepancies were found.The root cause of the reported event is due 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: TAPER EXT OFFSET RED NECK 5
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8128087
• MDR Text Key: 129196349
• Report Number: 0001822565-2018-06683
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K060040
• 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: 05/01/2019

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 Expiration Date: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 00771100540
• Device Lot Number: 61719278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/07/2018
• Initial Date FDA Received: 12/04/2018
• Supplement Dates Manufacturer Received: 04/24/2019
• Supplement Dates FDA Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1