MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SMARTSET GMV 40G US EO; BONE CEMENT : BONE CEMENT

Model Number 5450-35-500

Device Problems Loss of or Failure to Bond (1068); Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 05/26/2014

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

Loosening.

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.Update 01/22/2019 - re-open: received medical records there is no additional information that would change the existing investigation.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

Medical record ad (b)(6) 2019 was reviewed on (b)(6) 2019.(b)(6) 2014: the patient underwent a right total knee arthroplasty secondary to degenerative joint disease.Attune implants were used with depuy cement x2.The patella was resurfaced.No intraoperative complications were noted.(b)(6) 2018: the patient underwent a revision of the right knee secondary to pain, instability and suspected loosening.Intraoperatively, the surgeon noted that the tibial component was loose at the cement to implant interface.There were no intraoperative complications.Pmh: degenerative joint disease, right knee.Doi: (b)(6) 2014.Dor: (b)(6) 2018 (tibial base and insert).

Manufacturer Narrative

Patient code: no code available (3191) used to capture the medical device removal 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.

Manufacturer Narrative

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 been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.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.Device history lot: 6299529.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SMARTSET GMV 40G US EO
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 8077528
• MDR Text Key: 127357685
• Report Number: 1818910-2018-75743
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 10603295174288
• UDI-Public: 10603295174288
• Combination Product (y/n): N
• PMA/PMN Number: K033563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/02/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2015
• Device Model Number: 5450-35-500
• Device Catalogue Number: 545050501
• Device Lot Number: 6299529
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2018
• Initial Date FDA Received: 11/16/2018
• Supplement Dates Manufacturer Received: 01/22/2019; 12/06/2019; 05/06/2020
• Supplement Dates FDA Received: 01/25/2019; 12/11/2019; 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 32MM; ATTUNE PS FEM RT SZ 4 CEM
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR