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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/08/2017

Event Type  Injury  

Manufacturer Narrative

Patient was diagnosed with unilateral primary osteoarthritis left knee and was initially treated with scp.On (b)(6) 2017, the patient progressed to a total knee replacement after persistent pain.The investigation is in progress, and an additional report will be submitted once more information is available.

Event Description

Patient received tka after scp.

Manufacturer Narrative

Patient was diagnosed with unilateral primary osteoarthritis left knee and was initially treated with scp on (b)(6) 2017, the patient progressed to a total knee replacement after persistent pain.The tka was performed without complications.Additional information about the revision is unavailable, as the surgeon who performed the tka is unknown, as the event is driven from a clinical study.

Event Description

Patient received tka after scp.

• Brand Name: SUBCHONDROPLASTY
• Type of Device: SCP KIT
• Manufacturer (Section D): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer (Section G): ZIMMER KNEE CREATIONS, INC.; 841 springdale drive; exton PA 19341
• Manufacturer Contact: shari bailey ; 841 springdale drive; exton, PA 19341 ; 4848794543
• MDR Report Key: 7747448
• MDR Text Key: 115943452
• Report Number: 3008812173-2018-00026
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2018,08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2018
• Date Manufacturer Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 145