MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. SUBCHONDROPLASTY; SCP

Model Number N/A

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Host-Tissue Reaction (1297); Cyst(s) (1800); Unspecified Infection (1930)

Event Date 05/29/2018

Event Type  Injury  

Manufacturer Narrative

An email was received from a surgeon stating a patient may have experienced an infection with chronic osteomyelitis after the scp procedure, which was performed approximately three years ago.X-ray images of the area were received and will be reviewed as a part of the investigation.Once additional information becomes available, a supplemental report will be submitted.

Event Description

Patient appears to have developed an infection with chronic osteomyelitis as per the surgeon after receiveing scp.

Manufacturer Narrative

The observations and pictures reported in this complaint were documented at the time of the revision surgery.The excised section pictured in the attached intraoperative photos was sent for pathology screening and confirmed to be infected through the pathology report.The infection appears to have been related to index procedure.The patient was successfully treated by removing the accufill and treating the infection with an antibiotic laden lattice and is progressing well.

Event Description

Patient appears to have developed an infection with chronic osteomyelitis as per the surgeon after receiving scp.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer (Section G): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer Contact: shari bailey ; 841 springdale drive; exton, PA 19341 ; 4848794543
• MDR Report Key: 7621009
• MDR Text Key: 111734124
• Report Number: 3008812173-2018-00025
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other