MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER SEGMENTAL ARTICULAR SURFACE WITH SEGMENTAL HINGE POST SIZE C 14MM PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Staphylococcus Aureus (2058)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical products ¿ zimmer segmental polyethylene insert xt size c catalog #: 00585001396 lot #: 63914744, zimmer segmental distal xt femoral component size c catalog #: 00585004301 lot #: 63970726, zimmer segmental precoat tibial component size 4 catalog #: 00588000400 lot #: 63914801, zimmer segmental precoat tibial augment block size 4 10mm catalog #: 00588000410 lot #: 62013221, zimmer segmental precoat stem extension catalog #: 00585205013 lot #: 63786590, zimmer segmental stem collar catalog #: 00585204035 lot #: 64080211. The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital does not typically release implants and the sales representative was concerned about handling the infected prostheses. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2019-00897.

Event Description

It is reported that the patient underwent a left knee arthroplasty revision of the polyethylene components to address a (b)(6) that developed within approximately seven (7) weeks post-operatively. No additional patient consequences were reported.

Manufacturer Narrative

The product was evaluated through manufacturing review, however, the reported event was unable to be confirmed. The device history records were reviewed and no discrepancies were identified. Single-use, sterilized devices manufactured or distributed by zimmer biomet 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. Per package insert for the zimmer segmental system, infection is a known adverse effect of this procedure. However, a definitive root cause could not be determined with the information provided. 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

No further event information available at the time of this report.

• Brand Name: ZIMMER SEGMENTAL ARTICULAR SURFACE WITH SEGMENTAL HINGE POST SIZE C 14MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8369665
• MDR Text Key: 137120292
• Report Number: 0001822565-2019-00896
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K070978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 00585003014
• Device Lot Number: 63644221
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 02/26/2019 Patient Sequence Number: 1