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.

Manufacturer Narrative

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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned device identified fracturing, and not all pieces were returned.Further analysis of the device showed that it fractured due to fatigue.Medical records were also provided and confirmed a revision occurred on the patient due to fracturing of the device.Office notes stated that the patient was doing well postoperatively until they developed pathological pain in the right knee, causing them to bear all of their weight on the left extremity.Patient presented to the er where x-rays showed a fractured junction/connector piece.Device history record (dhr) was reviewed and no discrepancies were found.The patient was obese with medium activity level, which could have been a contributing factor to the event.However, a root cause cannot be determined.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: MOD ARTHRO NL 1CM DIASL CNCTR
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• 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
• PMA/PMN Number: K042409
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• 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: Health Professional
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 136