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	06/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient underwent an initial subchondroplasty procedure on (b)(6) 2017, and a synovectomy was performed concomitantly.The surgery proceeded as expected, and there were no intraoperative complications noted.On (b)(6) 2017, the patient returned to the due to post-operative pain, which was reviewed by the health care professional to be normal post-operative pain.Patient pain levels returned to normal after six weeks.The adverse event was assessed by the health care professional the device in question was not returned, as it remains implanted.A review of the dhr was conducted on the lot in question, and no anomalies related to the complaint condition were noted.
Event or Problem Description
Clinical subject: (b)(6) experienced post-operative pain.

• Brand Name: SUBCHONDROPLASTY
• Common Device Name: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 8842104
• Report Number: 3008812173-2019-00036
• Device Sequence Number: 1400775
• Product Code: OJH
• UDI-Device Identifier: 00889024205352
• UDI-Public: 00889024205352
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2019

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: 03/24/2020
• Device Model Number: N/A
• Device Catalogue Number: 514.315
• Device Lot Number: KC04058
• Was the Report Sent to FDA?: No
• Device Age: 2 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 07/30/2019
• 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: 308.151, LN: 36904
• Outcome Attributed to Adverse Event: Other
• Patient Age: 34 YR
• Patient Weight: 84