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 Extravasation (1842)

Event Type  Injury  

Manufacturer Narrative

The event has been sent to the fda with the uf/importer report # (b)(4).It was reported that accufill appeared to have leaked into the joint space postoperatively; the device was unable to be evaluated as it is retained in the patient.It was also reported that preexisting characteristics may have contributed to the event.Once more information becomes available about the event, a supplemental report will be submitted.Device remains in patient.

Event Description

Mdr received via mail-extravasation reported to fda.

Manufacturer Narrative

Through the investigation it was determined the event had previously been reported under report number 3008812173-2018-00012.The details of the event can be found in the previously reported event: "a patient returned to the surgeon after the scp case with a hematoma after possible extravasation near the site of the surgery.Images were taken but not available for review.Per the investigation, it was determined that the patient did not follow post-operative instructions from surgeon, resulting in the complaint condition.".

Event Description

Mdr received via mail-extravasation reported to fda.

• 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: 7561762
• MDR Text Key: 109818421
• Report Number: 3008812173-2018-00024
• 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: 05/01/2018,07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2020
• Device Model Number: N/A
• Device Catalogue Number: 514.303
• Device Lot Number: KC04137
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/01/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/29/2018
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2017
• 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 Weight: 75