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

Model Number 3122-040

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Joint Disorder (2373); No Code Available (3191)

Event Date 01/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient was revised to address loosening of the tibial component at the cement to implant interface.Cement manufacturer is depuy.Removal of attune knee due to pain.

Manufacturer Narrative

(b)(4) used to capture the medical device removal.

Event Description

Medical record ad 17 june 2019 was reviewed on 6 december 2019.Medical records report no intraoperative complications from initial implantation which included patella resurfacing and use of depuy cement x 2.This patient received right total knee arthroplasty with depuy implants (doi (b)(6) 2016) the right knee that was revised (dor (b)(6)2019) for reported pain and joint instability.Intraoperative findings tibial tray found loose at implant-cement interface.Patella was not revised.All other components were explanted (tibial, insert, femoral) and replaced with non-depuy revision knee system and non-depuy cement.No intraoperative complications during revision surgery.Doi (b)(6) 2016; dor: (b)(6) 2019 rt knee.

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 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.Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : device history reviewed on 19 dec 19 2 unrelated non-conformances on this lot number.Final micro and sterility tests passed.(b)(4) units released.Lot expiry date: 31 may 17.

• Brand Name: SMARTSET MV 40G - EO
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8276891
• MDR Text Key: 134066682
• Report Number: 1818910-2019-82240
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 10603295168379
• UDI-Public: 10603295168379
• Combination Product (y/n): N
• PMA/PMN Number: K081155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: 3122-040
• Device Catalogue Number: 3122040
• Device Lot Number: 8134383
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 32MM
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 83