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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Inflammation (1932); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Patient (b)(6) underwent an initial subchondroplasty procedure on (b)(6) 2018 for a stress fracture without complications; there were no concomitant procedures performed.The patient experienced increased pain 6 months post-operatively and received treatment in (b)(6) 2019; the specific event date is unknown.The operative notes and surgical documentation were received for the event.Additionally, the lot number for the device in question is known; the dhr will be reviewed as a part of the investigation.As additional information about the event is reported, a supplemental report will be submitted with any additional findings.

Event Description

Clinical subject (b)(6) experienced pain and inflammation after scp.

Event Description

Clinical subject (b)(6) experienced pain and inflammation.

Manufacturer Narrative

The patient underwent the initial scp procedure on (b)(6) 2018 with treatment of left medial first cuneiform with noted pre-operative stress fracture.There were no complications during the scp procedure, and no additional procedures were performed.The surgery proceeded as planned and post op pain scores are as anticipated.Patient presented at 6 month office visit with pain and inflammation and treated conservatively, the specific date of the event is unknown.Pain score at 12 month visit returned back to 2/10.The patient will continue to be monitored.If further information becomes available, the complaint investigation will be reopened.The dhr for the finished goods lot was reviewed, and no anomalies related to the complaint condition were noted.The product was not returned for evaluation, as it remains implanted.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 8697900
• MDR Text Key: 147995891
• Report Number: 3008812173-2019-00033
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 00889024205352
• UDI-Public: 00889024205352
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2021
• Device Model Number: N/A
• Device Catalogue Number: 514.315
• Device Lot Number: KC04845
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 5 MO
• Event Location: Hospital
• Date Manufacturer Received: 05/15/2019
• 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: 56 YR
• Patient Weight: 95