MAUDE Adverse Event Report: DEPUY CMW - 9610921 UNK CEMENT SMARTSET GMV; BONE CEMENT

Catalog Number UNK CEMENT SMARTSET GMV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Contracture (4528)

Event Date 06/23/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).No 510k as device is not marketed in the united states under this product code, but the same/similar product is marketed in the us under a different product code.Dmf# -(b)(4).Trade name gentamicin sulphate active ingredient(s) gentamicin sulphate dosage form ¿ powder strength 1.0g active in our cements.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 had severe rheumatoid arthritis and developed a significant flexion contracture.The surgeon's belief was the easiest way to address was to shorten the femoral side.The femoral component was removed, the femur resected until the knee would straighten and new components were placed with no complications or harm.No surgical delay.Doi: (b)(6) 2014.Dor: (b)(6) 2022.Affected side: left 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
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool IN FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14956203
• MDR Text Key: 295486540
• Report Number: 1818910-2022-12617
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK CEMENT SMARTSET GMV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2022
• 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: LPS CEMENTED STEM 9X100MM STR; LPS DISTAL FEM COMP XXSM LT; LPS UNIV TIB HIN INS XXSM 21MM; LPS XX-SM HINGE PIN
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 61 KG