MAUDE Adverse Event Report: DEPUY CMW ¿ 9610921 SMARTSET GHV GENTAMICIN 40G; BONE CEMENT : BONE CEMENT

Catalog Number 545035500

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Edema (1820); Unspecified Infection (1930); Pain (1994); Swelling (2091); Tissue Damage (2104); Discomfort (2330); Injury (2348); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 02/20/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(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

Attune litigation record received.Litigation record alleges pain, swelling, discomfort, difficulty ambulating,instability, infection, soft tissue injury and lack of bond/fixation, loosening at the cement to implant interface and failure of the implant, migration and fracture.Doi: (b)(6) 2015; dor: (b)(6) 2017, left knee.

Manufacturer Narrative

(b)(4) used to capture medical device removal.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
=
> the device associated with the reported event was not returned.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary = the device associated with the reported event was not returned.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.Patient code: no code available (3191) is used to capture joint instability.

• Brand Name: SMARTSET GHV GENTAMICIN 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW ¿ 9610921; cornford rd; blackpool IN FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 8562386
• MDR Text Key: 143475298
• Report Number: 1818910-2019-91925
• Device Sequence Number: 1
• Product Code: MBB
• 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
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2017
• Device Catalogue Number: 545035500
• Device Lot Number: 8053415
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR