MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET GMV 40G US EO; BONE CEMENT : BONE CEMENT

Model Number 5450-50-501

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Adhesion(s) (1695); Fall (1848); Pain (1994); Scar Tissue (2060); Ambulation Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)

Event Date 08/05/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A call from a customer was received wanted to make a complaint about the depuy synthes because the first one fails.The tibia was removed and undergone a surgery.The patient called to check if they ever settled out of court or if the patient needed to get an attorney.Doi: (b)(6) 2017.Dor: (b)(6) 2022.Unknown knee.

Manufacturer Narrative

Product complaint #
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> pc-(b)(4).Investigation summary
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> device associated with this report was not received for examination.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.Therefore the report allegation cannot be confirmed.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
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> 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 GMV 40G US EO
• 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 FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15950782
• MDR Text Key: 305175550
• Report Number: 1818910-2022-24924
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 20603295174292
• UDI-Public: 10603295174295
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 5450-50-501
• Device Catalogue Number: 545050501
• Device Lot Number: 8432638
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2016
• 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 3 CEM; ATTUNE FB TIB BASE SZ 3 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PATELLA MEDUALIZED DOME; ATTUNE PS FB INSRT SZ 5 10MM; ATTUNE PS FB INSRT SZ 5 10MM; ATTUNE PS FEM LT SZ 5 NAR CEM; ATTUNE PS FEM LT SZ 5 NAR CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 61 KG