MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MOD ARTHRO NL 1CM DIASL CNCTR PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Joint Dislocation (2374); No Code Available (3191)

Event Date 07/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical devices - modular arthrodesis nail diaphyseal connector 1cm, catalog #: cp260605, lot #: 236860; modular arthrodesis nail diaphyseal connector 1cm, catalog #: cp260605, lot #: 161950; orthopedic salvage system intramedullary stem 21. 5mm x 150mm, catalog #: 150400, lot #: 360910; orthopedic salvage system intramedullary stem 18. 5mm x 225mm, catalog #: 150405, lot #: 898500; unknown orthopedic salvage system femoral component, catalog #: ni, lot #: ni; unknown orthopedic salvage system tibial component, catalog #: ni lot #: ni; unknown orthopedic salvage system tibial bushing, catalog #: ni, lot #: ni; unknown orthopedic salvage system femoral bushing, catalog #: ni lot #: ni, unknown orthopedic salvage system yoke catalog #: ni, lot #: ni; unknown orthopedic salvage system axle, catalog #: ni, lot #: ni; unknown orthopedic salvage system locking pin, catalog #: ni, lot #: ni. The product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It is reported that the patient underwent a left knee arthroplasty revision approximately one (1) year and six (6) months post-operatively to address implant fracture. No additional patient consequences were reported.

• Brand Name: MOD ARTHRO NL 1CM DIASL CNCTR
• 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: 8863752
• MDR Text Key: 153365675
• Report Number: 0001825034-2019-03444
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042409
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: CP260605
• Device Lot Number: 236860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 02/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2018
• 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 Treatment Data

Date Received: 08/06/2019 Patient Sequence Number: 1