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

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem Unspecified Infection (1930)

Event Date 11/30/2017

Event Type  Injury  

Manufacturer Narrative

The complainant submitted the report to the manufacturer conservatively, as they were unsure if the scp surgery perform attributed to the patient infection.At this time there is not enough information to confirm the event, and a follow-up report will be submitted once more information is obtained.

Event Description

Possible infection after patient received scp foot & ankle.

Manufacturer Narrative

The operative notes from the event were received.The event occurred on (b)(6) 2017.The event was an infection and after getting prescribed antibiotics, the physician noted on (b)(6) 2017 that the drainage from the wound had stopped.By (b)(6) 2018, the patient had indicated to the physician that the pain at the surgical site had subsided and no longer needed additional assistance.

Event Description

Possible infection after patient received scp foot & ankle.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP KIT
• 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: 7357300
• MDR Text Key: 103026917
• Report Number: 3008812173-2018-00009
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2020
• Device Model Number: N/A
• Device Catalogue Number: 514.303
• Device Lot Number: KC04057
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2017
• 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
• Patient Age: 25 YR