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 Edema (1820); Pain (1994); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 06/28/2018

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

Patient was revised to address discomfort, lysis and loosening of the tibial component at the cement to implant interface.Unknown cement manufacturer.Doi: unknown.Dor: (b)(6) 2018; unknown affected side.

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.Device history lot : device history reviewed: 1 unrelated non-conformance on this lot.Final micro and sterility tests passed.Complaints database searched: a complaint database search on the provided lot number found 1 additional report, however this other incident did not relate to infection.Total for lot number: 2 ((b)(4)).

Event Description

On (b)(6) 2018, the patient underwent a right knee revision due to pain, discomfort, osteolysis, effusion, mild decreased range of motion, instability, and tibial tray loosening at the cement to implant interface.The femoral component was well-fixed and retained.The patella was resurfaced during the operation.

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.Device history lot device history reviewed: 1 unrelated non-conformance on this lot.Final micro and sterility tests passed.Complaints database searched: a complaint database search on the provided lot number found 1 additional report, however this other incident did not relate to infection.Total for lot number: 2 (b)(4).H10 additional narrative: added: b5, d6 and h6 (patient).Corrected: g3 and h4.No code available is used to capture joint instability and hemarthrosis.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).Corrected: d2b (procode).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).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.Removed: h6 (patient) hemarthrosis as this was populated in error and was reported in linked record.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: 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.Device history lot: device history reviewed: 1 unrelated non-conformance on this lot.Final micro and sterility tests passed.Complaints database searched: a complaint database search on the provided lot number found 1 additional report, however this other incident did not relate to infection.Total for lot number: 2 (b)(4).H10 additional narrative: dmf# - (b)(4), trade name gentamicin sulphate, active ingredient(s) gentamicin sulphate, dosage form - powder, and strength 1.0g active in our cements.

• 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
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9916247
• MDR Text Key: 187002756
• Report Number: 1818910-2020-09999
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174295
• UDI-Public: 10603295174295
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• 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 Model Number: 5450-50-501
• Device Catalogue Number: 545050501
• Device Lot Number: 8484059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2017
• 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 CR FEM RT SZ 4 NAR CEM; ATTUNE CR RP INSRT SZ 4 6MM; ATUNE CRS FB TIB BASE SZ 4 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female