MAUDE Adverse Event Report: DEPUY CMW - 9610921 DEPUY1 GENTAMICIN CEMENT 40G; BONE CEMENT : BONE CEMENT

Model Number 5450-31-500

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

Patient Problems Edema (1820); Erythema (1840); Unspecified Infection (1930); Pain (1994); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 08/26/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Clinical notification received for revision of left total knee to address deep infection.Date of implantation: (b)(6) 2020, date of revision: (b)(6) 2020, (left knee).Treatment: competitor insert components revised.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.

Event Description

On (b)(6) 2020, the patient underwent a primary left knee arthroplasty due to post-traumatic osteoarthritis with severe arhtrofibrosis and proximal tibial nonunion.The patient originally underwent the procedure due to a complicated and comminuted proximal tibia fracture following a recreational vehicle accident.The surgeon implanted competitor products with multiple depuy cement products.On (b)(6) 2020, the patient underwent a left knee revision due to infection, pain, swelling, difficulty walking, effusion, instability, and erythema.The surgeon noted gross pus within the knee with well-fixed component.An unknown manufactured screw that was previously identified as broken on x-ray on 28 may 2020 was removed.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Patient code: no code available (3191) is used to capture joint instability.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 worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.H10 additional narrative: details for gentamicin component of combination product: dmf# - (b)(4); trade name ¿ gentamicin sulphate; active ingredient(s) ¿ gentamicin sulphate; dosage form - powder; strength ¿ 1.0g active in our cements.

• Brand Name: DEPUY1 GENTAMICIN CEMENT 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 10528566
• MDR Text Key: 206772657
• Report Number: 1818910-2020-19960
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174264
• UDI-Public: 10603295174264
• Combination Product (y/n): N
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5450-31-500
• Device Catalogue Number: 545031500
• Device Lot Number: 9005013
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIOMET OSS AXLE; BIOMET OSS CO-CR YOKE; BIOMET OSS FEMORAL BUSHING; BIOMET OSS INTERLOCK BOWED IM STEM WITH SCREWS; BIOMET OSS LOCKING PIN; BIOMET OSS NON-MOD LONG TIBIAL BASE POR; BIOMET OSS POR/COAT RESURFACING FEM SZ 3, LT; BIOMET OSS TIBIAL BEARING 14MM; BIOMET OSS TIBIAL BUSHING; BIOMET VANGUARD KNEE SYSTEM; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; STRYKER MEDIUM UNIVERSAL CEMENT RESTRICTOR; STRYKER MEDIUM UNIVERSAL CEMENT RESTRICTOR; UNKNOWN BONE SCREW; BIOMET OSS AXLE; BIOMET OSS CO-CR YOKE; BIOMET OSS FEMORAL BUSHING; BIOMET OSS INTERLOCK BOWED IM STEM WITH SCREWS; BIOMET OSS LOCKING PIN; BIOMET OSS NON-MOD LONG TIBIAL BASE POR; BIOMET OSS POR/COAT RESURFACING FEM SZ 3, LT; BIOMET OSS TIBIAL BEARING 14 MM; BIOMET OSS TIBIAL BUSHING; BIOMET VANGUARD KNEE SYSTEM; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; STRYKER MEDIUM UNIVERSAL CEMENT RESTRICTOR; STRYKER MEDIUM UNIVERSAL CEMENT RESTRICTOR
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Weight: 82