MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 SMARTSET GMV 40G US EO; BONE CEMENT : BONE CEMENT

Catalog Number 545050501

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Fall (1848); Synovitis (2094); Discomfort (2330); Joint Laxity (4526)

Event Date 03/06/2023

Event Type  Injury  

Event Description

On (b)(6) 2015, the patient underwent a right total knee arthroplasty utilizing depuy synthes implants including patella and cement x 2.On (b)(6) 2023, the patient underwent a right knee revision secondary to discomfort, falls, joint instability, and a positive bone scan with suspected tibial loosening.Intraoperatively, hypertrophic synovial and granulation tissue was identified.Loosening at the implant to cement interface was confirmed.(b)(6) 2015 doi.(b)(6) 2023 dor (right knee).

Manufacturer Narrative

Product complaint # (b)(4).E3 initial reporter occupation: lawyer.Dmf# - (b)(4).Trade name ¿ gentamicin sulphate.Active ingredient(s) ¿ gentamicin sulphate.Dosage form ¿ powder.Strength ¿ 1.0g active in our cements.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.

• Brand Name: SMARTSET GMV 40G US EO
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY CMW 9610921; cornford rd; blackpool ; UK
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18894584
• MDR Text Key: 337553004
• Report Number: 1818910-2024-05706
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174295
• UDI-Public: 10603295174295
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2016
• Device Catalogue Number: 545050501
• Device Lot Number: 7942968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FB INSRT SZ 5 5MM; ATTUNE PS FEM RT SZ 5 NAR CEM; SMARTSET GMV 40G US EO
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female