MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS HO 17.0; PROSTHESIS - HIP

Catalog Number 51-107170

Device Problems Particulates (1451); Device Packaging Compromised (2916); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2015

Event Type  malfunction  

Manufacturer Narrative

The product was returned for evaluation.Engineer¿s evaluation relayed, "from the investigation, we can conclude that the most likely cause of the urethane particles being present in the blister would be due to movement of the hip / pouch in the blister caused by excessive handling and transportation.There was impact damage found on the tyvek blister as stated above.This type of damage is due to a heavy or sudden impact while being handled or transported.The production records have been checked and verified, with no anomies recorded.Therefore the implant was manufactured and packaged in line with the current packaging validation and protocol.The implant was conforming when it left are facility." - review of device history records found these units were released to distribution with no deviations or anomalies.- review of complaint history found no additional related issues for this item.Results of investigation relayed via etq notification to biomet (b)(4).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.(b)(4).

Event Description

It was reported that packaging was noted to be damaged when surgeon opened sterile package of taperloc complete microvolt at total hip replacement procedure.Urethane particles were found in the packaging from damage within the inner sterile tyvek layer.Another stem was used to complete the procedure.No adverse event occurred.

• Brand Name: TPRLC 133 MP TYPE1 PPS HO 17.0
• 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: 7017141
• MDR Text Key: 92662622
• Report Number: 0001825034-2017-10138
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK110400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/10/2017

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: 10/31/2021
• Device Catalogue Number: 51-107170
• Device Lot Number: 2474144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/26/2015
• Initial Date FDA Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2011
• 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