MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 DEPUY1 GENTAMICIN CEMENT 40G; BONE CEMENT : BONE CEMENT

Catalog Number 545031500

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Pain (1994)

Event Date 01/23/2024

Event Type  Injury  

Event Description

Surgeon said the patient complained of pain months after their primary knee surgery.He thought they may have aeseptic loosening since they did not show any signs of infection.He removed all components and waited on cultures to make sure the patient was not infected and replaced implants with attune revision components.All components seemed to be cemented on well.Bone and cement were still on the flat part of the tibial tray.Sales rep did not observe any cement on the cone of the tibial component.No one mentioned their being any problems with our implants.It was unknown about surgical delay.Doi: on (b)(6) 2022, dor: on (b)(6) 2024, affected side: right knee.

Manufacturer Narrative

Product complaint#: (b)(4).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.Dmf#: 13704, trade name: gentamicin sulphate, active ingredient(s): gentamicin sulphate, dosage form: powder, strength: 1.0g active in our cements.

Manufacturer Narrative

Product complaint #(b)(4).Investigation summary: no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required lot number was not provided to complete the 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.If additional information is made available, the investigation will be updated as applicable.Device history lot : a non-conformance search for the provided lot number/product code combination was conducted and no reports related to the reported event were found.

• Brand Name: DEPUY1 GENTAMICIN CEMENT 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: 18613440
• MDR Text Key: 334204673
• Report Number: 1818910-2024-02095
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174264
• UDI-Public: 10603295174264
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 545031500
• Device Lot Number: 9905843
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2021
• 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 PS FEM RT SZ 4 CEM; ATTUNE PS RP INSRT SZ 4 8MM; ATTUNE RP TIB BASE SZ 3 CEM; DEPUY1 GENTAMICIN CEMENT 40G
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female