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

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Host-Tissue Reaction (1297)

Event Date 05/11/2018

Event Type  Injury  

Manufacturer Narrative

A health care professional reported that a patient came to him seeking a second opinion about her ankle.After reviewing the images, he noticed the lesion growing.He communicated that the patient was seeking options to additional treatment.The images are currently unavailable.Once additional information is received, a supplemental report will be submitted.

Event Description

Patient claims scp procedure qi 2017- chronic pain-lesion small to large.

Manufacturer Narrative

The reporting surgeon and hospital was unwilling to submit patient information and radiographic images.Additionally, it was unable to determine if the complaint was caused by zimmer knee creations bone void filler or that from some other source.No other additional information was made available; therefore, the nature and cause of the complaint incident is indeterminate.

Event Description

Patient claims scp procedure qi 2017- chronic pain-lesion small to large.

• 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: 7537150
• MDR Text Key: 109021584
• Report Number: 3008812173-2018-00021
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2018
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other