MAUDE Adverse Event Report: DEPUY CMW - 9610921 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 Adhesion(s) (1695); Muscular Rigidity (1968); Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 09/09/2020

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

Clinical adverse event received for arthrofibrosis- stiffness/unable to get good rom.Event is not serious and is considered moderate.Event is definitely not related to both device and is definitely related to procedure.Date of implantation: (b)(6) 2020, date of event (onset): (b)(6) 2020, (right knee).Treatment: knee manipulation under anesthesia ((b)(6) 2020).

Manufacturer Narrative

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

Event Description

Medical records was received and reviewed.On (b)(6) 2020, the patient had a cemented right total knee arthroplasty to address osteoarthritis of the right knee.Depuy components, including depuy patella and depuy cement x2 were utilized.There were no complications noted during the procedure.On (b)(6) 2020, the patient had a manipulation of right total knee with intraarticular injection of cortisone and bupivacaine with iv sedation, due to arthrofibrosis, pain and lack of motion of the right knee.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: details for gentamicin component of combination product: dmf# - (b)(4); 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 report, a follow-up report will be filed as appropriate.

• Brand Name: SMARTSET GMV 40G US EO
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 10587736
• MDR Text Key: 208576065
• Report Number: 1818910-2020-20938
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174295
• UDI-Public: 10603295174295
• Combination Product (y/n): N
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 5450-50-501
• Device Catalogue Number: 545050501
• Device Lot Number: 9292945
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FEM RT SZ 6 CEM; ATTUNE PS RP INSRT SZ6 5MM; ATTUNE RP TIB BASE SZ 5 CEM; ATTUNE RP TIB BASE SZ 6 CEM; SMARTSET GMV 40G US EO; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FEM RT SZ 6 CEM; ATTUNE PS RP INSRT SZ6 5MM; ATTUNE RP TIB BASE SZ 5 CEM
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 91