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

Model Number 5450-50-501

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Erosion (1750); Cyst(s) (1800); Pain (1994); No Code Available (3191)

Event Date 01/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Depuy smartset ghv litigation letter received.Depuy smartset ghv litigation letter alleged that plaintiff experienced severe pain, which x-rays revealed gross loosening of the tibial component of a competitor left knee prosthetic, which loosening was causing the erosion of plaintiff's right tibia.Doi: (b)(6) 2016; dor: (b)(6) 2019 right knee.

Manufacturer Narrative

Product complaint # (b)(4).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.  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).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Medical records were reviewed to identify patient harms/product issues.Right knee: in addition to the previous harms reported prior to revision, the patient was also experiencing instability, lysis under the tibial tray, and cyst.

Event Description

Medical records captured neurological issues surrounding the patient's cervical fusion surgery performed on (b)(6) 2018.

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.H10 additional narrative: added: b5, b7, h6 corrected: b1, b2.H6 patient code: no code available (3191) was used to capture joint instability.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).Investigation summary: the device associated with this report was not received for examination.Review of the device history records did not reveal any non-conformances.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 22 aug 19.0 non-conformances on this lot number.Final micro and sterility tests passed.(b)(4) units released.Expiry date: 31-oct-17.

• 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: 9226945
• MDR Text Key: 163729191
• Report Number: 1818910-2019-111576
• 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: other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 5450-50-501
• Device Catalogue Number: 545050501
• Device Lot Number: 8209381
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CR FEMORAL; CR FEMORAL; CR TIBIAL BEARING; CR TIBIAL BEARING; MODULAR FINNED STEM WITH SCREW; MODULAR FINNED STEM WITH SCREW; PATELLA SINGLE PEG WITH WIRE; PATELLA SINGLE PEG WITH WIRE; PRIMARY TIBIAL MODULAR TRAY WITH LOCKING BAR; PRIMARY TIBIAL MODULAR TRAY WITH LOCKING BAR; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR