MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DEPUY1 GENTAMICIN CEMENT 40G; BONE CEMENT : BONE CEMENT

Catalog Number	545031500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was referred post tka for infection.Surgeon choses to perform a one stage revision tka with a dual set up and placement of resorbable antibiotic beads.All well fixed were components removed and a thorough irrigation and debridement (i&d) was performed prior to prepping for new components.A portion of the anterior tibia came off when the tibia component was removed however the sleeve had good fixation when prepared.No delay was experienced.There was no loosening but depuy cement has been used.Doi: (b)(6) 2024.Dor: (b)(6) 2024.Affected side: right knee.
Additional 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# (b)(4).Trade name: gentamicin sulphate.Active ingredient(s): gentamicin sulphate.Dosage form: powder.Strength: 1.0g active in our cements.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.According to the information received, "it was reported that the patient is referred post tka for infection.Surgeon choses to perform a one stage revision tka with a dual set up and placement of resorbable antibiotic beads.All well fixed were components removed and a thorough i&d is performed prior to prepping for new components.A portion of the anterior tibia came off when the tibia component was removed however the sleeve had good fixation when prepared.No delay was experienced.There was no loosening but depuy cement has been used.Doi: (b)(6) 2024.Dor: (b)(6) 2024.Affected side: right knee".A manufacturing record evaluation was performed for the finished device product code- 545031500, lot - 3861174 and no non-conformances / manufacturing irregularities were identified.Manufacturing date: 06 sep 2022.Expiry date: 31 aug 2025.Quantity: (b)(4).Product checked: retained samples.Required testing: tm-t150 cement setting time there is one non-conformances associated with this batch.On review of the applicable nc it has been identified that the nc would not have contributed to the complaint event.The samples returned were tested in a temperature and humidity-controlled laboratory.Lot: 3861174 dough time: 01 min 22s (spec: 02 min 00s max) mix characteristics: soft.Setting time: 08 min 40s (spec: 07 min to 10 min 30s).The cement mixed and behaved as expected for the product type and met the appropriate control specification.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- 545031500, lot - 3861174 and no non-conformances / manufacturing irregularities were identified.

• Brand Name: DEPUY1 GENTAMICIN CEMENT 40G
• Common Device Name: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• 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: 19361822
• Report Number: 1818910-2024-11199
• Device Sequence Number: 3785414
• Product Code: MBB
• UDI-Device Identifier: 10603295174264
• UDI-Public: 10603295174264
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K081163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Catalogue Number: 545031500
• Device Lot Number: 3861174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEPUY1 GENTAMICIN CEMENT 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 56 KG