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	Calcium Deposits/Calcification (1758)
Date of Event	01/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At a six week post operative follow-up visit, the physician noticed calcification in the lateral vascular bundles of a patient who underwent subchondroplasty.The patient had experienced acute pain immediately post-op.X-ray images were provided for review.The device was not returned for investigation as it remains implants.The finished good lot dhr was reviewed and no anomalies were noted.As additional information about the event is reported, a supplemental report will be submitted with any additional findings.
Event or Problem Description
Calcification and acute pain after scp.
Event or Problem Description
Calcification and acute pain after scp.
Additional Manufacturer Narrative
Scp surgery was reported to have been performed on the foot or ankle of the patient with no complications on (b)(6) 2019.On (b)(6) 2019, following surgery, it was reported immediate post-op there was acute pain but there was no heel pain.Three attempts were made to contact the sales representative about the reported event; however, the sales representative was unable to be reached to discuss the event.X-ray images were provided.Visual in the x-ray can be seen some calcification of the venous structure surrounding the posterior heel.Calcification of some areas of venous structure following the scp procedure has been observed and reported previously in other clinical complaints.Upon further consult with expert surgeons and follow up, usually it has been determined that similar calcification was resolved and had not resulted in any further complication, injury, or pain.The opinion of faculty surgeons consulted was that this occurrence usually is not a cause for further concern and normally resolves over time.If any additional information becomes available about the event, a supplemental report will be submitted.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 the investigation, as it remains implanted in the patient.

• Brand Name: SUBCHONDROPLASTY
• Common Device Name: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• MDR Report Key: 8544650
• Report Number: 3008812173-2019-00022
• Device Sequence Number: 19440801
• Product Code: OJH
• UDI-Device Identifier: 00889024205321
• UDI-Public: 00889024205321
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2019

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: 10/11/2019
• Device Model Number: N/A
• Device Catalogue Number: 414.503
• Device Lot Number: KC03475
• Was the Report Sent to FDA?: No
• Device Age: 27 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 09/20/2019
• 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
• Outcome Attributed to Adverse Event: Other