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

Model Number 5450-31-500

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Muscular Rigidity (1968); Necrosis (1971); Pain (1994); Ambulation Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 10/17/2022

Event Type  Injury  

Event Description

Clinical adverse event received for failed patellar component.Patellar migration/loosening.Event is serious and is considered severe.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2020; date of event: (b)(6) 2022; (left knee).Treatment: revision; patella and insert were revised.

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.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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned for analysis.Review of the photographic evidence was not able to confirm the complaint, in order to confirm loosening a series of chronological x-rays is needed.No other defects were identified.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.

Event Description

Medical records received.Patient reports pain, stiffness, and walking difficulty in left knee 2 years s/p left knee revision of tibial tray and patella due to loosening.Physical exam identifies sizable effusion as well as 1-2 mm laxity with extension.Imaging indicates a failure of the patella.The patient will return for a detailed exam with the surgeon.Clinic note dated (b)(6) 2022: the surgeon determines the natural paella has fractured due to avascular necrosis.There is no indication of failure of the patellar button.The surgeon performs a joint aspiration of 70 ml from the left knee.The patient will continue to be monitored.No further intervention was provided.

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.H10 additional narrative: added: b5, h6 health effect - clinical code.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: DEPUY1 GENTAMICIN CEMENT 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; cornford rd; blackpool 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: 15742794
• MDR Text Key: 303142445
• Report Number: 1818910-2022-22178
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174264
• UDI-Public: 10603295174264
• 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: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5450-31-500
• Device Catalogue Number: 545031500
• Device Lot Number: 9322352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/07/2022
• Supplement Dates Manufacturer Received: 11/03/2022; 12/09/2022
• Supplement Dates FDA Received: 11/23/2022; 12/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2020
• 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 RP INSRT SZ 5 10MM; ATTUNE RP TIB BASE SZ 4 CEM; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: White