MAUDE Adverse Event Report: UNK CEMENT SMARTSET GMV; BONE CEMENT

Catalog Number UNK CEMENT SMARTSET GMV

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Pain (1994)

Event Date 07/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient has pain in femur.X-rays show a loose femoral stem where the cement did not hold to the bone.Cement would be gmv but is hospital owned so no lot information is available in our records.An attune fully porous femoral sleeve and stem were placed uneventfully.No surgical delay.Doi: (b)(6) 2020; dor: (b)(6) 2021; right knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre) was not possible because the required lot code was not provided.

• Brand Name: UNK CEMENT SMARTSET GMV
• Type of Device: BONE CEMENT
• MDR Report Key: 12658617
• MDR Text Key: 277207275
• Report Number: 1818910-2021-22959
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK CEMENT SMARTSET GMV
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2021
• Initial Date FDA Received: 10/19/2021
• Supplement Dates Manufacturer Received: 10/29/2021
• Supplement Dates FDA Received: 10/29/2021
• 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
• Patient Sequence Number: 1
• Treatment: ATTUNE REV LPS INSRT XXSM 12MM; LPS CEMENTED STEM 10X100MM STR; LPS DISTAL FEM COMP XXSM RT; LPS SEGMENTAL COMPONENT 125MM; LPS SEGMENTAL COMPONENT 35MM; UNK CEMENT SMARTSET GMV; ATTUNE REV LPS INSRT XXSM 12MM; LPS CEMENTED STEM 10X100MM STR; LPS DISTAL FEM COMP XXSM RT; LPS SEGMENTAL COMPONENT 125MM; LPS SEGMENTAL COMPONENT 35MM; UNK CEMENT SMARTSET GMV
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 93