MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 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 Pain (1994); No Code Available (3191)

Event Date 09/26/2017

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 der states that patient was revised to address pain and loosening of the tibial component.

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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese 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.¿ added: d11 and h6 (patient).No code available is used to capture device revision or replacement.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : a previous device history record (dhr) review on legacy complaint com-102683 was conducted by the manufacture site.Review of the device history records did not reveal any related manufacturing deviations or anomalies against this lot.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.Corrected: d2b.

• Brand Name: SMARTSET GMV 40G US EO
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9505708
• MDR Text Key: 184889964
• Report Number: 1818910-2019-124464
• 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: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Model Number: 5450-50-501
• Device Catalogue Number: 545050501
• Device Lot Number: 3546937
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 35MM.
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 79