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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 12/08/2016

Event Type  Injury  

Manufacturer Narrative

Specific details of the complaint were found in the operative notes and post operative follow up progress notes reported in the clinical study.Operative notes: subchondroplasty(scp) was performed on the medial tibia; during the procedure there was report of extravasation of injected material into the soft tissues near the injection site of the medial tibia.The incision at the site was extended and the extravasation area was irrigated.Two (2) week progress notes: portal sites are reported to be benign; mild pain that is controlled; no report of inflammation at the scp area.Six (6) week progress notes: pain is mild at treatment area; portal sites have mild drainage of excess bone graft; patient reports having pain at the portal site; the site was irrigated and bone graft material was expressed.Seven (7) week progress notes: knee pain is mild; portal sites continue to have drainage; patient reports improvement from the previous irrigation.Ten (10) week progress notes: knee pain is mild; portal sites continue to have drainage; decision was made to perform surgery for irrigation and debridement of the tissues at the site.The 2nd surgery operative notes: the subcutaneous tissues were accessed by opening the same incision from previous treatment; during dissection a previous arthrotomy portal was found; bone graft material was irrigated from the subcutaneous tissues.Twelve (12) week follow-up (2 wk after 2nd surgery): pain is now moderate and occasional; mild drainage at the surgical site; lab report states normal white blood count.Sixteen (16) week follow-up: pain is moderate; continues to have moderate drainage at the site on (b)(6) 2017 3rd surgery performed for irrigation and debridement of the previous surgical site.Two (2) week and 6 week post op: patient has mild pain of the knee; improving symptoms, mild drainage; patient continues to have treatment at the wound clinic.Summary: the patient had subchondroplasty treatment during which there was extravasation of material into the soft tissues; the irrigation and debridement was conducted during the surgery and in follow-up surgeries.The patient continued to have reaction and drainage at the surgical site - it was noted that it appeared that the bone graft material was being expelled during the drainage.Due to the numerous invasive procedures the exact cause of the tissue reaction cannot be pinpointed however it could be likely due to the extravasation of material into the tissues during surgery and the specific patient's reaction to the extravasation in the tissues.In the patient history there was some history of smoking reported in the patients past; no other extenuating factors were noted.Dhr's of the product involved were reviewed including evidence of sterilization;no non-conformances were noted in the review of the dhr reports.Not returned.

Event Description

Research study subject diagnosed with an infected right knee after scp, possibly related to procedure per dr.(b)(6).

Manufacturer Narrative

Through a non-routine review of the complaint file, it was recognized that the incorrect part number was submitted on the initial medwatch, report number 3008812173-2017-00017, on (b)(6) 2017.This medwatch is being submitted to correct the product information.

Event Description

Possible infection after scp.

• 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: 6724155
• MDR Text Key: 80403037
• Report Number: 3008812173-2017-00017
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 402.202
• Device Lot Number: KC03426
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2016
• 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: 59 YR