MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA FIXED BEARING POSTERIOR STABILIZED ARTICULAR SURFACE LEFT 12MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Staphylococcus Aureus (2058); Swelling (2091)

Event Date 01/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: persona cemented stemmed tibial component left size h, catalog #: 42532008301, lot #: 63659225.Persona cemented posterior stabilized standard femoral component left size 11, catalog #: 42500607001, lot #: 63792191.Persona all poly patella 38mm, catalog #: 42540000038, lot #: 63764241.The product was evaluated through manufacturing review and the complaint was confirmed through review of medical records.The device history records were reviewed and no discrepancies were identified.Per the persona knee system package insert, infection is a known potential adverse effect of this procedure.Single-use, sterilized devices manufactured or distributed by zimmer are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is highly unlikely that the specified device caused any patient infection.The medical records additionally state that the patient used a sewing needle to puncture one of the blisters around his incision site.While the presence of the blister indicates that an infection was likely already present, introducing a nonsterile object into or near the wound is highly likely to cause or contribute to infection.The root cause is considered to be a human factors issue.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 was previously submitted erroneously on jan 19, 2018 and nov 7, 2018 under manufacturing report number 0001822565-2018-00454.

Event Description

It is reported that the patient underwent a left knee arthroplasty revision of the polyethylene articular surface with irrigation and debridement to address a staphylococcus infection approximately one (1) month post-operatively.The patient received intravenous antibiotics for six (6) weeks and continued with oral antibiotics until antibiotic treatment was complete.It is additionally reported that the patient has fully recovered and experienced no further complications.

• Brand Name: PERSONA FIXED BEARING POSTERIOR STABILIZED ARTICULAR SURFACE LEFT 12MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8286118
• MDR Text Key: 134378155
• Report Number: 0002648920-2019-00042
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 42511401012
• Device Lot Number: 62604175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2014
• 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
• Patient Outcome(s): Hospitalization; Required Intervention