MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SMARTSET GHV GENTAMICIN 40G; BONE CEMENT : BONE CEMENT

Catalog Number 545035500

Device Problems Failure To Adhere Or Bond (1031); Loss of or Failure to Bond (1068)

Patient Problems Adhesion(s) (1695); Pain (1994); Not Applicable (3189); No Code Available (3191)

Event Date 05/10/2018

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Der states patient came to see the surgeon complaining of knee pain since his primary knee was implanted.The surgeon decided to take him to surgery to check components for loosening.The femoral component was stable but the tibial component was loose at cement to implant interface and needed to be revised.The surgeon commented that the tibial component did not have any cement on the underside.The original tibial component had been implanted with depuy ghv bone cement but unable to get lot # since the hospital buys their cement directly from depuy.He removed all the cement from tibia and implanted attune rev tray sleeve and stem.He replaced with an appropriate size poly.Doi: (b)(6) 2017.Dor: (b)(6) 2018; left knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Device history lot: null.Device history batch: null.Device history review: null.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

Pc-(b)(4) no device associated with this report was received for examination.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.H10 additional narrative: added: a2, b5, d2b, d4 (lot, catalog, expiration date, udi), d11, g5, h4, h6 (no code available (3191) is used to capture the surgical intervention and medical device removal) corrected: a1, b3, d1, d2.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 received on 14 jan 2020 were reviewed to identify patient harms/product issues on (b)(6) 2020.The patient underwent a left knee revision due to pain and tibial tray loosening at the cement to implant interface.The femoral and patellar components were retained.The surgeon noted excising scar tissue aroung the patella, patellar tendon, quadriceps tendon, back of knee, and suprapatellar pouch and gutters.Two depuy cement products were used during the primary operation.Doi: (b)(6) 2017 dor: (b)(6) 2018 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.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H10 additional narrative:.

• Brand Name: SMARTSET GHV GENTAMICIN 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7572848
• MDR Text Key: 110179518
• Report Number: 1818910-2018-61414
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• PMA/PMN Number: K033563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 545035500
• Device Lot Number: 8502538
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE PS FEM LT SZ 8 CEM
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR