MAUDE Adverse Event Report: DEPUY CMW - 9610921 DEPUY/CMW 2G; BONE CEMENT : BONE CEMENT

Model Number 5450-32-500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Fibrosis (3167); No Code Available (3191)

Event Date 03/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Clinical adverse event received for arthrofibrosis left knee.Event is serious and is considered mild.Event is not related to device and is definitely related to procedure.Date of implantation: (b)(6) 2019; date of event (onset): (b)(6) 2020; (left knee).Treatment: manipulation under anesthesia.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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.Dmf# - (b)(4).Trade name ¿ gentamicin sulphate.Active ingredient(s) ¿ gentamicin sulphate.Dosage form - powder.Strength ¿ 1.0g active in our cements.

Manufacturer Narrative

Product complaint #: (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

Manufacturer Narrative

Product complaint # (b)(4).Patient code: no code available (3191) used to capture the absence of treatment.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

This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

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: corrected: g1 (physical manufacturer), h6 (patient).No code available (3191) was used to capture serious injury.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: DEPUY/CMW 2G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 9954626
• MDR Text Key: 187881082
• Report Number: 1818910-2020-10678
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174271
• UDI-Public: 10603295174271
• Combination Product (y/n): N
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5450-32-500
• Device Catalogue Number: 545032500
• Device Lot Number: 8939042
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE FEM NAR POR PS LT SZ 5; ATTUNE MEDIAL ANAT PAT 38MM; ATTUNE PS RP INSRT SZ 5 7MM; ATTUNE RP TIB BASE SZ 6 POR; DEPUY/CMW 2G
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 79