MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARKER LT TRIFLANGE 68ID WP; PROSTHESIS, HIP

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).No product was returned for visual or dimensional evaluations.A photo of the product was provided, for which nothing could be concluded as the picture depicted the opened, empty component bags after surgery.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause was unable to be determined.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.Report source: event occurred in (b)(6).

Event Description

It was reported that during a revision procedure, it was noticed that the product to be implanted was missing two locking caps in the packaging.Due to the lack of components, the surgeon chose to implant a drill bit into the patient to prevent the implant from backing out.This resulted in a 35 minute surgical delay.Attempts have been made and no further information has been provided.

• Brand Name: PARKER LT TRIFLANGE 68ID WP
• 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: 10065048
• MDR Text Key: 193622898
• Report Number: 0001825034-2020-02000
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00887868353420
• UDI-Public: (01)00887868353420
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PM0002102
• Device Lot Number: 721680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/07/2020
• Initial Date FDA Received: 05/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other