MAUDE Adverse Event Report: ZIMMER KNEE CREATIONS, INC. SUBCONDROPLASTY

Model Number N/A

Device Problem Device Issue (2379)

Patient Problem Pain (1994)

Event Date 10/05/2017

Event Type  Injury  

Event Description

Patient recvd tka after scp.

Manufacturer Narrative

On january 3rd, an updated adverse event report was received stating that the adverse event was not related to the procedure.Therefore the event is no longer classified as a serious injury or reportable event.

Event Description

Patient recv'd tka after scp.

• Brand Name: SUBCONDROPLASTY
• Type of Device: SUBCONDROPLASTY
• 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: 7027545
• MDR Text Key: 91892492
• Report Number: 3008812173-2017-00025
• 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: study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 10/18/2017
• 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 Age: 60 YR
• Patient Weight: 95