MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC STANDARD OFFSET FEMORAL STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.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

It was reported that the product was found to be protruding through the inner packaging and out of the box.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Lot: expiration date: oct 31, 2024.(b)(4).Complaint sample was evaluated and the reported event was confirmed.Review of the returned packaging and product determined that the stem has punctured through the inner pouch and the blister and almost completely punctured through the cardboard box.The outer carton ends also show signs of impact damage on the ends.Dhr was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to damage during transit and a packaging design deficiency.The root cause associated with the inadequate packaging validations is that there was no procedure for carrying out packaging worst case assessments.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: TAPERLOC STANDARD OFFSET FEMORAL STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6978076
• MDR Text Key: 90876925
• Report Number: 0001825034-2017-09671
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK120030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/15/2018

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 51-100040
• Device Lot Number: 3433009
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2017
• Initial Date FDA Received: 10/25/2017
• Supplement Dates Manufacturer Received: 09/05/2018
• Supplement Dates FDA Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1