MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL COMPONENT PRECOAT SIZE 4 PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration (4003)

Patient Problem Bacterial Infection (1735)

Event Date 01/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-00730, 0001822565-2019-00731, 0001822565-2019-00732, 0001822565-2019-00733, 0001822565-2019-00734, and 0001822565-2019-00735. Concomitant medical devices: distal femoral xt component size b right catalog#: 00585004202 lot#: ni, segment with male/female taper 140 mm length catalog#: 00585004614 lot#: ni, segment with male/female taper 30 mm length catalog#: 00585004603 lot#: ni, articular surface with segmental hinge post size b 12 mm height catalog#: 00585002012 lot#: ni, stem extension straight 18mm dia x 100mm length catalog#: 00598801018 lot#: ni. Report source: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital would not release the devices. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent right knee arthroplasty. Subsequently, patient underwent irrigation, debridement, and replacement of components due to suspected infection and tibial loosening.

• Brand Name: TIBIAL COMPONENT PRECOAT SIZE 4
• 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: 8348509
• MDR Text Key: 136492559
• Report Number: 0001822565-2019-00734
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K013385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 00588000400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 02/18/2019 Patient Sequence Number: 1