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 Necrosis (1971)

Event Date 05/24/2018

Event Type  Injury  

Manufacturer Narrative

Patient developed avn after scp procedure of the talus, and the patient will progress to a total ankle replacement.Radiographic images were available and will be reviewed as a part of the investigation.Once the investigation results are reported, a supplemental report will be submitted.

Event Description

Patient developed avn after scp of talus.

Manufacturer Narrative

Patient developed avn after scp procedure of the talus, and the patient will progress to a total ankle replacement.Radiographic images were reviewed as a part of the investigation.It is possible that length of the procedure with a tourniquet contributed to development of avn.However, a definitive root cause cannot be determined, as there are many factors involved, including the treatment method.

Event Description

Patient developed avn after scp of talus.

• 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: 7562105
• MDR Text Key: 109828140
• Report Number: 3008812173-2018-00023
• 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: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 514.303
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/01/2018
• Supplement Dates Manufacturer Received: 05/24/2018
• Supplement Dates FDA Received: 08/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2018
• 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: 56 YR