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

Model Number N/A

Device Problem Biological Environmental Factor (2887)

Patient Problems Host-Tissue Reaction (1297); Inadequate Pain Relief (2388)

Event Date 01/29/2018

Event Type  Injury  

Manufacturer Narrative

Patient returned about one month after the scp procedure with complaints of increased pain, and radiographs appeared normal.The patient returned on (b)(6) with continued pain and x-rays showed concern of possible stress fracture.On (b)(6) the stress fracture was confirmed by a ct.A follow-up report will be submitted with the results of the investigation.

Event Description

Clinical study subject received scp and presented with a possible stress fracture.

Manufacturer Narrative

Operative notes from the case were received and indicate that the procedure occurred without any adverse events; however, changes from grade 2 to grade 4 were noted in the medial cartilage and grade 0 in lateral compartment that attributed to the complaint condition.

Event Description

Clinical study subject received scp and presented with a possible stress fracture.

• 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: 7403915
• MDR Text Key: 104597911
• Report Number: 3008812173-2018-00015
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2020
• Device Model Number: N/A
• Device Catalogue Number: 414.502
• Device Lot Number: KC04323
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Event Location: Outpatient Treatment Facility
• Date Manufacturer Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2017
• 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: 67 YR
• Patient Weight: 97