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 11/30/2016

Event Type  Injury  

Manufacturer Narrative

The event was first brought to the attention of zimmer on nov 30, 2016 and was investigated.The complaint engineer was able to speak with a partner of the complainant, on march 16, 2017.The partner was familiar with and had reviewed the cases referenced by the complainant.The partner confirmed that several painful scp patients have been treated by the practice.Several of these patients had progressed on to total knee arthroplasty (tka).Additionally, the partner was not aware of any dead bone attributed to this complaint but did say the practice has an academic question regarding the impact of accufill on surrounding trabecular bone.He recognized the revised scp cases as being progression of disease.The initial report was filed under (b)(4) on april 25th, 2019 under mfr number 3008812173-2019-00024.The customer had indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.The investigation has been reopened for further investigation.Once the investigation has been competed, a follow-up mdr will be submitted.

Event Description

During a (b)(6) course in (b)(6), a distributor reported that a surgeon conversed about 8 scp cases as also evaluating the product in an unfavorable way.The distributor attending also reported that the surgeon went as far as to report he found numerous cases of dead bone after the scp procedures.

Manufacturer Narrative

The initial date of the event is (b)(6) 2016.The event was re-opened in may 2019 to further investigate.Three attempts have been made to dr.(b)(6) regarding the event; however, there was no response from dr.(b)(6) or his team for additional information on this group of patients.Dhr review was unable to be conducted, as the part number and lot number were unknown.There was no device returned as a part of this event.

Event Description

During a master oxford course in (b)(6), a distributor reported that a surgeon conversed about 8 scp cases as also evaluating the product in an unfavorable way.The distributor attending also reported that the surgeon went as far as to report he found numerous cases of dead bone after the scp procedures.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 8601532
• MDR Text Key: 144756982
• Report Number: 3008812173-2019-00027
• 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: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 11/30/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other