MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK CEMENT GENTAMICIN; BONE CEMENT

Catalog Number UNK CEMENT GENTAMICIN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Blister (4537)

Event Date 10/15/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Trade name gentamicin sulphate, active ingredient(s) gentamicin sulphate, dosage form - powder, strength 1.0g active in our cements.Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient was revised due to loosening of the tibial and femoral sleeves at the bone to implant interface.It was reported that patient came in with what appeared to be blisters on his thigh.Cultures were negative but surgeon felt as though infection was likely.A superficial exposure was performed finding 2 tracts leading down to the implant through the muscle and capsule.All components were removed.After a thorough i&d was performed, a spacer was fashioned using lps components.This was coated with high dose antibiotic cement and antibiotic beads were placed.Neither of the components were ingrown further pointing to the fact that the patient was still infected.These implants were put in on separate dates, the first section was placed on (b)(6) 2021, while the second group was placed on (b)(6) 2020.The femoral side was revised on (b)(6) 2021 but the tibial components were left in place as they appeared.Doi: (b)(6) 2021 (femoral components & tibial insert), (b)(6) 2020 (tibial tray), unknown (tibial sleeve & tibial stem), dor: (b)(6) 2021, right knee.

• Brand Name: UNK CEMENT GENTAMICIN
• Type of Device: BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12846715
• MDR Text Key: 281074907
• Report Number: 1818910-2021-25515
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK CEMENT GENTAMICIN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: ATT REV SLV LPS FEM ADP +5; ATTUNE REV LPS INSRT XXSM 12MM; ATUN FEM SLV M/L 30MM FULL POR; ATUN TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM18X60MM; ATUNE PRESSFIT STR STEM18X60MM; ATUNE REV RP TIB BASE SZ 3 CEM; CONTROL CABLE W/CABLE SLEEVE; LPS DISTAL FEM COMP XXSM RT; LPS SEGMENTAL COMPONENT 125MM; LPS SEGMENTAL COMPONENT 45MM; UNK CEMENT GENTAMICIN
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 93 KG