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

Model Number 5450-50-501

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Local Reaction (2035)

Event Date 02/14/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Occupation: lawyer.Dmf#: 13704.Trade name: gentamicin sulphate.Active ingredient(s): gentamicin sulphate.Dosage form: powder.Strength: 1.0g active in our cements.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

(b)(6) 2016: patient underwent a left knee attune arthroplasty.The patella was resurfaced, and cement manufacturer was depuy.There were no complications noted.(b)(6) 2019: patient underwent a left knee revision after presenting with knee pain and aspectic failure.The femoral and tibial components were revised with minimal bone loss.The patella was noted to be well fixed without excessive wear and wasn¿t revised.Hypertropic synovium was excised.Attune revision implants were placed during the revision.Doi: (b)(6) 2016 dor: (b)(6) 2019 left knee.

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 may be re-opened as necessary.Device history lot: device history reviewed: no non-conformances on this lot number.Final micro and sterility tests passed.Complaints database searched: a complaint database search finds 1 additional related report against the provided product and lot combination.Total for lot number: 2 (b)(4).

• Brand Name: SMARTSET GMV 40G US EO
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10898416
• MDR Text Key: 218250513
• Report Number: 1818910-2020-25443
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174295
• UDI-Public: 10603295174295
• Combination Product (y/n): Y
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: 5450-50-501
• Device Catalogue Number: 545050501
• Device Lot Number: 8178371
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2021
• 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 5 CEM; ATTUNE PS RP INSRT SZ 5 8MM; ATTUNE RP TIB BASE SZ 6 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FEM LT SZ 5 CEM; ATTUNE PS RP INSRT SZ 5 8MM; ATTUNE RP TIB BASE SZ 6 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR