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 Type  Injury  

Manufacturer Narrative

It was reported in slovenia that a patient had an allergic reaction after an scp procedure.No additional information is available at this time.Once additional information becomes available, a supplemental report will be submitted.

Event Description

Possible allergic reaction to scp.

Event Description

Possible allergic reaction to scp.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported under (b)(4).

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 7550934
• MDR Text Key: 109481114
• Report Number: 3008812173-2018-00020
• 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
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• 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
• Date Manufacturer Received: 05/09/2018
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other