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

Model Number 5450-50-501

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Synovitis (2094); Swelling/ Edema (4577)

Event Date 10/26/2020

Event Type  Injury  

Event Description

Patient received a right attune total knee to treat osteoarthritis.The patella was resurfaced and depuy cement x 2 was utilized.There were no indicated intra-operative complications.Patient received a right knee revision to address pain, swelling, synovitis, and tibial tray loosening at the cement to implant interface.The tibial insert, tibial tray, and femoral component were revised.The patella component was retained.The patient was revised with competitor products and cement.There were no indicated intra-operative complications.Doi: (b)(6) 2017.Dor:(b)(6) 2020.Right knee.

Manufacturer Narrative

(b)(4).Initial reporter occupation: (b)(6).(b)(4).Trade name: (b)(6).Active ingredient(s): (b)(6).Dosage form: (b)(6).Strength: (b)(6).If information is obtained that was not available for the initial 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.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.Depuy considers the investigation closed.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: 1 unrelated non conformance on this batch.Micro and sterility tests passed.Complaints database searched: a complaint database search on the provided lot number found 6 additional reports, all related to implant loosening.Total for lot number: 7 (b)(4).Complaints received by cmw in the last 12 months for this issue ¿ by product code: 95.By product family: 155 (108x smartset gmv, 47x smartset ghv).

• Brand Name: SMARTSET GMV 40G US EO
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd.; blackpool IN FY4 4 QQ; UK FY4 4QQ
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12825036
• MDR Text Key: 284650392
• Report Number: 1818910-2021-25287
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174295
• UDI-Public: 10603295174295
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 5450-50-501
• Device Catalogue Number: 545050501
• Device Lot Number: 8326335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 12/07/2021
• Supplement Dates FDA Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL ANAT PAT 41MM; ATTUNE PS FEM RT SZ 8 CEM; ATTUNE PS RP INSRT SZ8 5MM; ATTUNE RP TIB BASE SZ 8 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White