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

Catalog Number 545035500

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Joint Laxity (4526); Swelling/ Edema (4577)

Event Date 06/22/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.Dmf# - (b)(4).Trade name gentamicin sulphate, active ingredient(s) gentamicin sulphate, dosage form - powder, strength 1.0g active in our cements.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Attune litigation record received.Litigation record alleges pain, swelling, decreased range of motion, varus knee deformity, large medical proximal tibial defect and aseptic loosening of the tibial implant at the cement to implant interface.Depuy cement was used.Due to the extensive deformity and severe bone loss damage making the revision surgery more complex, the patient developed lack of ankle dorsiflexion and decreased sensation.The patient was diagnosed with left sided foot drop likely caused by deep peroneal nerve injury.During the revision surgery, the patient also sustained a stroke event that caused impaired short-term memory.Doi: (b)(6) 2014, dor: (b)(6) 2020, left knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : no lot information available.

Event Description

Medical records received indicated that on (b)(6) 2014, the patient had a left total knee arthroplasty and arthrocentesis of right knee to address degenerative joint disease of the left and right knee.Depuy components, including depuy patella and depuy cement x1, were used during this procedure.On (b)(6) 2019.The patient reported having increasing pain.Radiographs were noted to show varus alignment of the tibial component with what appears to be lucency around the tibial tray and possible subsidence.In (b)(6) 2020, the patient had an aspiration and no growths were noted on (b)(6) 2020, the patient had a left revision to address loose left tibial tray with varus knee deformity and large medial proximal tibial defect.During the procedure, the surgeon observed tibial bone loss, with well-fixed femoral and patellar components and laxity to varus and valgus stress.The tibial tray was noted to be loose at the implant/cement interface.The femoral component was revised, the patella remained in situ.The tibial tray was noted to have migrated laterally.There was extensive bone loss.Competitor components were used during this procedure, including competitor cement x4.Doi: (b)(6) 2014 dor: (b)(6) 2020 (left knee) post revision on (b)(6) 2020, the patient notes numbness medial and lateral aspect of knee.

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.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.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SMARTSET GHV GENTAMICIN 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool IN FY4 4 QQ; UK FY4 4QQ
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool IN FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12217481
• MDR Text Key: 263141569
• Report Number: 1818910-2021-15858
• Device Sequence Number: 1
• Product Code: MBB
• 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: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: 545035500
• Device Lot Number: 7786783
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2014
• 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 FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FB INSRT SZ 5 5MM; ATTUNE PS FEM LT SZ 5 NAR CEM; UNK CEMENT GENTAMICIN; ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FB INSRT SZ 5 5MM; ATTUNE PS FEM LT SZ 5 NAR CEM; UNK CEMENT GENTAMICIN
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female