MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SMARTSET GMV 40G US EO; BONE CEMENT : BONE CEMENT

Catalog Number 545050501

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 11/14/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Dmf# - 13704 trade name ¿ gentamicin sulphate active ingredient(s) ¿ gentamicin sulphate dosage form - powder strength ¿ 1.0g active in our cements.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Event Description

Voluntary report received: the patient's wife reported that the patient had right knee replaced in 2017.The surgical procedure appeared to have gone well for about the first three months.Then patient began or continued to have pain in his right knee.Patient followed up with the surgeon who did x-rays and found no issues.The problems continued and patient again went in for one-year post op appointment.Patient was told that sometimes knee joints don't fit as well for some patients.The pain continued and became so intense at the beginning of 2023 that patient sought assistance from a different surgical group.The x-rays immediately showed that the orthopedic joint was moving in patient's leg.Patient would have to have a revision surgery for correction.Patient had this surgery on (b)(6) 2023.It was told by the surgeon that the original replacement failed before patient¿s knee was even closed up as none of the cement adhered to any part of the artificial joint.The new surgeon had to do extensive debridement of the bones as the cement was in the bones.Patient told both parts of the original replacement just popped out.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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 records evaluation (mre) was not perform.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.If additional information is made available, the investigation will be updated as applicable.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 GMV 40G US EO
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18968495
• MDR Text Key: 338487996
• Report Number: 1818910-2024-06473
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174295
• UDI-Public: 10603295174295
• 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
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 545050501
• Device Lot Number: 8378515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2016
• 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 MEDIAL ANAT PAT 38MM; ATTUNE PS FEM RT SZ 8 CEM; ATTUNE PS RP INSRT SZ 8 10MM; ATTUNE RP TIB BASE SZ 7 CEM; SMARTSET GMV 40G US EO
• Patient Outcome(s): Required Intervention