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

Model Number 5450-32-500

Device Problems Loss of or Failure to Bond (1068); Loss of Osseointegration (2408)

Patient Problems Fall (1848); Pain (1994); Joint Disorder (2373); No Code Available (3191)

Event Date 02/01/2018

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.(b)(4).Initial reporter occupation: attorney.

Event Description

Patient fell 6-7 months post-op with increasing pain a few months after the fall.X-rays and bone scan showed loosening and mechanical failure of tibial baseplate as well as subsidence of the baseplate medially with the component in significant varus.Failure also noted at the cement to bone interface laterally.A revision was completed on (b)(6) 2018 using a competitor implants, explanting the depuy femoral component, tibial baseplate, and poly insert, as well as an unknown tibial screw.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4) used to capture medical device removal.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 : 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.H10 additional narrative: added: h6 (patient).Corrected: b1, b2, d3, g1 (physical manufacturer), h6 (device).

• Brand Name: DEPUY/CMW 2G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool IN FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 8277680
• MDR Text Key: 134092808
• Report Number: 1818910-2019-82297
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174271
• UDI-Public: 10603295174271
• Combination Product (y/n): N
• PMA/PMN Number: K061144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5450-32-500
• Device Catalogue Number: 545032500
• Device Lot Number: 8016675
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 112