MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET GMV 40G US EO; BONE CEMENT : BONE CEMENT

Catalog Number 545050501

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 12/19/2018

Event Type  Injury  

Manufacturer Narrative

(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

The patient was revised to address loosening of an unknown component at an unknown interface.

Manufacturer Narrative

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

Event Description

Revision operative notes indicate the patient received a left revision on (b)(6) 2018 due to massive tibial bone loss and loosening of the tibial tray.Upon entering the knee, the tibial tray was found to be grossly loose at an unknown interface and easily removed.The was femoral component well-fixed but revised.The patella was well-fixed and retained.There was no reported product problem with the explanted tibial insert.The procedure was completed without complications.Revision product information was not provided.

Manufacturer Narrative

Product complaint # (b)(4).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.  h10 additional narrative: added: a2, b5, d2b, d4 (catalog, lot, udi, expiration date), d11, g5, h4, h6 (no code available (3191) is used to capture the device revision or replacement).Corrected: a1, d1, d2.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : device history reviewed 25 nov 2019 2 unrelated non-conformances on this lot number.Final micro and sterility tests passed.(b)(4) units released.Lot expiry date: 28 february 2018.

• Brand Name: SMARTSET GMV 40G US EO
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford road; blackpool IN FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 8247821
• MDR Text Key: 133056345
• Report Number: 1818910-2019-80940
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 545050501
• Device Lot Number: 8279527
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2020
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FEM LT SZ 5 CEM; ATTUNE PS RP INSRT SZ 5 7MM; ATTUNE RP TIB BASE SZ 5 CEM
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR