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

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/29/2012

Event Type  Injury  

Manufacturer Narrative

The patient was omitted to the hospital for pain post the scp surgery and two emergency room visits.After staying overnight, the patient was released the next morning with oral medications and feeling better.If any additional information regarding the event becomes available, a followup report will be submitted.

Event Description

The clinical site reported the subject had postoperative pain in their study knee.

Manufacturer Narrative

At the time of her release, the patient was comfortable taking the oral medical and having been off pca for greater than 12 hours.It was noted upon the patient's release that the incision was healing without erythema or drainage and no focal pain to palpation.

Event Description

Postoperative pain.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 7530485
• MDR Text Key: 108790703
• Report Number: 3008812173-2018-00019
• 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,study,use
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• 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
• Event Location: Hospital
• Date Manufacturer Received: 04/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22 YR
• Patient Weight: 91