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

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/12/2018

Event Type  Injury  

Manufacturer Narrative

Patient returned to a health care facility after having insufficient pain relief after and initial scp procedure.During evaluation, the health care facility noticed a foreign body/mass in the knee joint that had migrated distally in the tibia.The foreign body was removed and sent to a lab for further analysis.An additional report will be submitted once new information is available.

Event Description

Foreign body located beneath tissue on top of the tibia plateau.

Manufacturer Narrative

The product was requested, but not returned.The foreign body was sent to a lab for further analysis by the hospital; however, the hospital was unwilling to disclose the lab results or the x-ray images from the case.The regional director stated it appeared as though the material in the original surgery might have extravasated through an existing fracture or defect in the bone.

Event Description

Foreign body located beneath tissue on top of the tibia plateau.

• 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: 7219165
• MDR Text Key: 98233949
• Report Number: 3008812173-2018-00004
• 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: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 01/12/2018
• 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: 56 YR