MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. CPLT F&A KIT 3CC 15G END; 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	08/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is not a complaint.Patient underwent the scp procedure on (b)(6) 2017, and a matrixectomy of 3rd and 4th digits on the left foot was performed concomitantly.The surgical and operative notes were returned for the investigation, and no intraoperative complications were noted.At two weeks postoperatively, the patient returned due to increased pain, which went unresolved until twelve months postoperatively.On (b)(6) 2018, the patient underwent open reduction internal fixation (orif) of the left 3rd metatarsal with dorsal plate and screw.The event was evaluated by the by the investigator as mild in intensity, possibly related to the procedure and not device related.The event was communicated on (b)(4) 2019.The dhr for the raw material and finished goods lot was reviewed, and no anomalies related to the complaint condition were noted.The product was not returned for evaluation, as it remains implanted.
Event or Problem Description
Clinical subject: (b)(4) experienced pain after scp.
Additional Manufacturer Narrative
Per zimmer knee creations capa ca-05425, this medwatch was identified for remediation, as the products listed in d11 in the initial submission were components of the finished kit for which this medwatch was filed under and should not have been reported.
Event or Problem Description
Clinical subject 02-005 experienced pain after scp.

• Brand Name: CPLT F&A KIT 3CC 15G END
• Common Device Name: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 8842627
• Report Number: 3008812173-2019-00039
• Device Sequence Number: 10834230
• Product Code: OJH
• UDI-Device Identifier: 00889024205352
• UDI-Public: 00889024205352
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2020

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: 04/25/2020
• Device Model Number: N/A
• Device Catalogue Number: 514.315
• Device Lot Number: KC04138
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/02/2019
• Device Age: 3 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 09/14/2020
• 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 201.030 LN 101992.; PN 308.151 LN 36493.; PN 308.151 LN 36859.; PN 201.030, LN 101992; PN 308.151, LN 36493; PN 308.151, LN 36859
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR
• Patient Weight: 88