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

Model Number N/A

Device Problems No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 10/13/2017

Event Type  Injury  

Manufacturer Narrative

Patient went to clinic after experiencing continuous pain after scp procedure.Initial surgery date was (b)(6) 2017.Mris have been requested.The investigation is ongoing; once additional information becomes available, a supplemental report will be submitted.

Event Description

Patient complains of pain after recieving scp.

Manufacturer Narrative

The pre-op and follow-up mri¿s were reviewed by a clinical consultant.Upon the review, it was observed that the patient had a bone lesion before the initial scp surgery.After surgery, the initial lesion area appeared to be resolved, but a new lesion has appeared near the original one, as well as other mechanical complications in the same knee.The original bml is consistent with the typical treatment of bone marrow lesions, and the pain is most likely attributed to the progression of arthritic disease and appearance of a new bml.

Event Description

Patient complains of pain after recieving 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: 7747435
• MDR Text Key: 115937504
• Report Number: 3008812173-2018-00027
• 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: 08/03/2018

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 Expiration Date: 04/17/2020
• Device Model Number: N/A
• Device Catalogue Number: 414.502
• Device Lot Number: KC04029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 1 YR
• Event Location: Other
• Date Manufacturer Received: 06/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2017
• 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: 55 YR