MAUDE Adverse Event Report: DEPUY CMW - 9610921 DEPUY CMW 1G 40G; BONE CEMENT : BONE CEMENT

Catalog Number 3315040

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 12/10/2022

Event Type  Injury  

Event Description

Patient had attunne primary knee surgery.30 days after the surgery, she began with persistent pain and discomfort while walking.The dr.Detected a loosening in the tibial plateau, therefore it must be replaced, performing tibial revision.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? unknown, did the patient require revision surgery or hardware removal? unknown, patient status/ outcome / consequences : no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study : unknown, ip (b)(4), device property of : none, device in possession of : none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.

Manufacturer Narrative

Product complaint # (b)(4).Dmf# (b)(4).Trade name gentamicin sulphate, active ingredient(s) gentamicin sulphate, dosage form - powder, strength 1.0g active in our cements.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial , a follow-up will be filed as appropriate.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary; no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot; a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.H10 additional narrative: added: d6a, d6b corrected: d3, g1.

Event Description

Additional information received: a.Was there a surgical delay during revision surgery? what was the length of the delay? there was no surgical delay.B.Tibial loosening was indicated.Please provide the loosening interface, cement manufacturer.If depuy cement was used, provide details and the quantity of the product.: the doctor detected the loosening of the plate, and the patient reported pain.Depuy 3315040 2-dose cement was used.C.What is the affected side? left or right? left side.

• Brand Name: DEPUY CMW 1G 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd.; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16351851
• MDR Text Key: 309277310
• Report Number: 1818910-2023-03450
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): Y
• Reporter Country Code: CI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3315040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• 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 FB TIB BASE SZ 3 CEM; DEPUY CMW 1G 40G; UNK ATTUNE KNEE TIBIAL INSERT; UNKNOWN KNEE FEMORAL
• Patient Outcome(s): Required Intervention