MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SMARTSET GHV GENTAMICIN 40G; BONE CEMENT : BONE CEMENT

Model Number 5450-35-500

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Edema (1820); Pain (1994); Weakness (2145); Joint Disorder (2373); No Code Available (3191)

Event Date 12/11/2018

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.Initial reporter occupation: non-healthcare professional "attorney".(b)(4).

Event Description

The patient was revised to address pain and loosening of the tibial component at the cement to implant interface.Unknown cement was used.It was reported that the radiograph showed tibial radiolucency around the component.On (b)(6) 2018, the patient underwent a left knee revision due to tibial loosening at the cement to implant interface, tibial tray subsidence, tibial tray malposition, swelling, pain, instability, stiffness, and weakness.Doi: (b)(6) 2015; dor: (b)(6) 2018; left knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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: device history reviewed: 0 non-conformances on this lot number.Final micro and sterility tests passed.All qc release specficiations met.(b)(4) units released.

• Brand Name: SMARTSET GHV GENTAMICIN 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 9459143
• MDR Text Key: 185502038
• Report Number: 1818910-2019-122774
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174288
• UDI-Public: 10603295174288
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: 5450-35-500
• Device Catalogue Number: 545035500
• Device Lot Number: 7951011
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FEM LT SZ 6 CEM
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR