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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient under the index scp procedure on (b)(6) 2018 on their left foot.Debridement and a synovectomy were performed concomitantly.On (b)(6) 2018, the patient went to the emergency room and intravenous pain medication was delivered.The patient was discharged on (b)(6) 2018.The clinical project lead was notified of the event on (b)(6) 2019.The investigator from the hospital site evaluated the event as moderate in intensity, definitely related to the procedure and possibly related to the implant with the comment that this was expected post-op pain in a patient with low pain tolerance.The device was not returned for investigation as it remains implanted.As new information becomes available, a supplemental report will be submitted.
Event or Problem Description
Clinical subject (b)(6) experienced increased pain after scp.
Event or Problem Description
Clinical subject (b)(6) experienced pain after scp.
Additional Manufacturer Narrative
Patient under the index scp procedure on (b)(6) 2018 on their left foot.Debridement and a synovectomy were performed concomitantly.On (b)(6) 2018, the patient went to the emergency room and intravenous pain medication was delivered.The patient was discharged on (b)(6) 2018.The clinical project lead was notified of the event on 21 june 2019.The investigator from the hospital site evaluated the event as moderate in intensity, definitely related to the procedure and possibly related to the implant with the comment that this was expected post-op pain in a patient with low pain tolerance.This complaint is being closed on the basis of normal pain associated with surgical procedure.Patient is retained in study and continues to be monitored for adverse events.The device was not returned for investigation as it remains implanted.The dhr for the lot in question was reviewed, and no anomalies related to the complaint condition were noted.

• Brand Name: SUBCHONDROPLASTY
• Common Device Name: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 8802141
• Report Number: 3008812173-2019-00034
• Device Sequence Number: 319896
• Product Code: OJH
• UDI-Device Identifier: 00889024205277
• UDI-Public: 00889024205277
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 402.203
• Device Lot Number: KC05134
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN 201.050, LN 1021210239; PN 307.034, LN 37102; PN 201.050, LN 1021210239; PN 307.034, LN 37102
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR
• Patient Weight: 101