MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSYS HIP SYSTEM - FEMORAL STEM FIBER METAL TAPER COLLARLESS 12/14 NECK TAPER; PROSTHESIS, HIP

Model Number N/A

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

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

Event Date 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number - (b)(4).The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported during a left hip arthroplasty that the implant had completely punctured the hard plastic and the tip was sticking out of the packaging.The procedure was delayed approximately five minutes and another device was used to complete the procedure.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

Visual examination of the returned device packaging confirms the reported damage.Dhr was reviewed and no discrepancies were found.Root cause is atrributed 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 information available at the time of this reporting.

• Brand Name: VERSYS HIP SYSTEM - FEMORAL STEM FIBER METAL TAPER COLLARLESS 12/14 NECK TAPER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7741597
• MDR Text Key: 115767025
• Report Number: 0001822565-2018-03629
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK964769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

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 Model Number: N/A
• Device Catalogue Number: 00786201130
• Device Lot Number: 62975026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2018
• Initial Date FDA Received: 08/01/2018
• Supplement Dates Manufacturer Received: 06/19/2019
• Supplement Dates FDA Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 70