MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OXF UNI TIB TRAY SZ C LM PMA; PROSTHESIS - KNEE

Catalog Number 154722

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Fall (1848); Unspecified Infection (1930)

Event Date 06/15/2015

Event Type  Injury  

Manufacturer Narrative

The product had been discarded and was, therefore, not available for return.Without the opportunity to examine the complaint product, root cause cannot be determined.It is believed a patient fall may have led to the infection and subsequent loosening.Review of complaint history found no additional related issues for this item.Review of device history records found these units were released to distribution with no deviations or anomalies.Completion of the investigation relayed to sales rep via email.Review of sterilization certification confirms devices were sterilized in accordance with iso (b)(4).Condition is addressed in package insert.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.This report is being submitted late as it has been identified in remediation.(b)(4).

Event Description

It was reported that patient underwent left partial knee arthroplasty on (b)(6) 2013.Subsequently, patient fell one month later and opened the wound.The surgeon did a washout and poly change on (b)(6) 2013 due to possible infection.Surgeon believes tibial component may have loosened at the time.Patient was revised for a loose tibial component on (b)(6) 2015.

• Brand Name: OXF UNI TIB TRAY SZ C LM PMA
• Type of Device: PROSTHESIS - KNEE
• 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: 7040215
• MDR Text Key: 92300812
• Report Number: 0001822565-2017-07938
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/16/2017

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 Expiration Date: 08/31/2023
• Device Catalogue Number: 154722
• Device Lot Number: 312230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2015
• Initial Date FDA Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2013
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR