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

Model Number 5450-35-500

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Adhesion(s) (1695); Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Pain (1994); Ambulation Difficulties (2544); Confusion/ Disorientation (2553); Swelling/ Edema (4577)

Event Date 03/17/2020

Event Type  Death  

Event Description

Patient received a right primary attune to treat severe end-stage arthritis.The patella was resurfaced and depuy cement x 2 was utilized.The surgeon notes that the patient had a preexisting left bka that was performed to treat a clotting issue.The procedure was completed without complications.Patient received a right knee revision to treat pain, swelling, and inability to walk secondary to aseptic loosening.The patient has extensive comorbidities.Because of this, he was given dialysis and extensive treatments for his preexisting clotting disorder before being approved for the revision and cleared for the procedure.Upon entering the joint, scar tissue was debrided from the joint.The tibial tray was grossly loose and debonded at the cement to implant interface and easily removed.The femoral component and patella were both loose at an unknown interface and revised.There was no reported product problem with the revised tibial insert.The patient was revised with competitor products.The procedure was completed without complications.Hours after the revision.The patient had an episode of hypotension and confusion and was transferred to the icu.Dialysis was attempted but was discontinued as the hypotension returned.Ct scan revealed significant ischemic and dead bowel.The family and physicians conversed, and corrective surgery was declined.Patient was given comfort measures and expired on the second post-operative day.There is insufficient information provided to determine the root cause of the death and the depuy synthes products cased or contributed to the reported death two days after the revision.Doi: (b)(6) 2016; dor: (b)(6) 2020; dod: (b)(6) 2020; right knee.

Manufacturer Narrative

(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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for 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.However, if the product is received at a later date, the investigation will be updated as applicable.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (nc search) was performed for the finished device 545035500, and lot 8159147, no non-conformances / manufacturing irregularities related to the malfunction were identified.

• Brand Name: SMARTSET GHV GENTAMICIN 40G
• Type of Device: 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13664733
• MDR Text Key: 286553691
• Report Number: 1818910-2022-04055
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174288
• UDI-Public: 10603295174288
• 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
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: 5450-35-500
• Device Catalogue Number: 545035500
• Device Lot Number: 8159147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2015
• 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 MEDIAL DOME PAT 38MM.; ATTUNE PS FEM RT SZ 7 CEM.; ATTUNE PS RP INSRT SZ7 5MM.; ATTUNE RP TIB BASE SZ 6 CEM.; SMARTSET GHV GENTAMICIN 40G.
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Race: Black Or African American