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

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 03/27/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was likely discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that on an unknown date, the patient had underwent a subchondroplasty procedure to the knee.Subsequently, the patient was revised to a tka system due to alleged failure of the subchondroplasty procedure.Attempts have been made and no further information has been provided.

Event Description

Revision of subchondroplasty to complex tka.

Manufacturer Narrative

The complainant reported that a tka was conducted on a patient that had received a bone void filler injection for treatment of a bml.It is unclear who the index surgeon was or if the product was in fact accufill.The complainant reported that he had revised this patient to a tka due to progressive disease which he attributed to the index procedure.Op notes and post op documentation of the tka were requested but the complainant was not compliant in supplying further information.Pre-op x-rays were provided and reviewed by the radiologist on the clinical advisory board.Based on the limited information supplied, it was proposed that the radiographs indicated possible boney infarction which may or may not be related to the index procedure.This clinical investigation has been hampered by the lack of clinical information from both the index surgery and the conversion to tka.This complaint is being closed on the basis of progression of disease.If further information is available, this complaint will be reopened further a more in depth clinical evaluation.The dhr was unable to be reviewed, as the lot number for the device related to the event was unable to be confirmed.The product was not returned for the investigation, as it remains implanted in the patient.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 8549238
• MDR Text Key: 143055645
• Report Number: 3008812173-2019-00023
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 08/16/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 03/27/2019
• Supplement Dates FDA Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention