MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD.8010379 LCS COMP MODREV FEM CEM L STD+; KNEE FEMORAL COMPONENT

Catalog Number 129442050

Device Problems Fracture (1260); Loss of Osseointegration (2408)

Patient Problems Inflammation (1932); Pain (1994); No Information (3190); No Code Available (3191)

Event Date 05/05/2014

Event Type  Injury  

Event Description

Fracture of the femur component - patient had to be revised.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

Notification was received from bioengineering stating that the root cause is undetermined.Based on the information received and the investigation performed, the root cause of the need for revision was undetermined.The customer did not report a device defect.It is not possible to determine if there was a manufacturing fault.No corrective action is required.A review of manufacturing records and complaints database search did not identify any anomalies.The complaint shall be closed with an undetermined conclusion it will be entered into the complaint database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Update 27-apr-2017: medical records received.After review of the medical records for mdr reportability, the revision operative note indicated pain, effusion, instability, medial loosening (implant/cement), worn poly, broken medical femoral component, and femoral lysis.Its reasonable to conclude the loosening and worn/damaged poly is a result of the fractured medial component (per implant pictures provided).There is no new information that would change the existing mdr decision.

Manufacturer Narrative

Fracture of the femur component - patient had to be revised the reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LCS COMP MODREV FEM CEM L STD+
• Type of Device: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD.8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD.8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 3818475
• MDR Text Key: 4391435
• Report Number: 1818910-2014-19021
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/01/2015
• Device Catalogue Number: 129442050
• Device Lot Number: 3148187
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2010
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 83