MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 SMARTSET GHV GENTAMICIN 40G; BONE CEMENT : BONE CEMENT

Catalog Number 545035500

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Pain (1994)

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported that there was an depuy attune knee replacement that expired premature.Doi: (b)(6) 2018.Dor: unknown.Affected side : left knee.Additional event information provided by patient stating that patient had a left total knee done in (b)(6) 2018 and has been experiencing pain.The patient had radiographs done that are reported to show that there is loosening of the "top and bottom" (tibial tray and femoral component).The patient is scheduling a revision and would be interested in compensation as he had heard his knee was in a recall.Patient provided part/lot numbers for the components, including the cement.

Manufacturer Narrative

Product complaint #: (b)(4).B3: date of event is an unknown date.E3: the initial reporter information has been removed for confidentiality/privacy.The initial reporter is a patient.Dmf# - 13704.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 : no device associated with this report was received for examination.A manufacturing record evaluation was performed for the finished device product code:545035500, lot number:8554715, and no non-conformances / manufacturing irregularities related to the malfunction were identified manufacturing date: 2017-06-09, expiry date: 2019-05-31, quantity: (b)(4).There was 1 non-conformances on this lot.On review of the applicable ncs none have been identified which would contribute to the complaint event.All qc and microbiology testing met specification.A review of the dhr has confirmed that there were no process issues documented that could contribute to the event described.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.If additional information is made available, the investigation will be updated as applicable.Device history lot : a manufacturing record evaluation was performed for the finished device product code:545035500, lot number:8554715, and no non-conformances / manufacturing irregularities related to the malfunction were identified.

• Brand Name: SMARTSET GHV GENTAMICIN 40G
• 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 FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17939203
• MDR Text Key: 325730044
• Report Number: 1818910-2023-21024
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174288
• UDI-Public: 10603295174288
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 545035500
• Device Lot Number: 8554715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2017
• 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 PS FEM LT SZ 6 CEM; ATTUNE PS RP INSRT SZ6 5MM; ATTUNE RP TIB BASE SZ 6 CEM; UNK ATTUNE KNEE PATELLA
• Patient Outcome(s): Required Intervention
• Patient Sex: Male