MAUDE Adverse Event Report: DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS LCS COMP RP INSERT STD+ 12.5MM; KNEE TIBIAL BEARING/INSERT

Catalog Number 129405512

Device Problem Metal Shedding Debris (1804)

Patient Problems Host-Tissue Reaction (1297); Pain (1994)

Event Date 03/14/2014

Event Type  Injury  

Event Description

Procedure: knee revision.Original surgery was performed on (b)(6) 2010.Revision surgery was performed on (b)(6) 2014.Reason for revision: patient presented with pain.Surgeon performed biopsy prior to revision.During revision, metal debris was evident in the biopsy.Surgeon had noted that metal debris was evident in the soft tissue and there was significant synovitis.There were scratches on femoral component in the orientation of superior to interior.Implants were removed, soft tissue debrided, the knee was prepped and a revision tibial and femoral were implanted.The surgeon is convinced that this was due to a failure of the lcs duofix tibial component and is encouraging the patient to take legal action.

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

(b)(4).Further investigation was completed by applied research and bioengineering, with a report received 18-june-14, concluding: root cause: 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.The complaint shall be closed with an undetermined conclusion; it shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be investigated further.

• Brand Name: LCS COMP RP INSERT STD+ 12.5MM
• Type of Device: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS; 325 paramount drive; reg. # 1219655; raynham MA 02767
• Manufacturer (Section G): DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS; 325 paramount drive; reg. # 1219655; raynham MA 02767
• Manufacturer Contact: stacey trick ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714554
• MDR Report Key: 3730879
• MDR Text Key: 4328278
• Report Number: 1818910-2014-16103
• Device Sequence Number: 1
• Product Code: NJL
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 129405512
• Device Lot Number: BFI01G0000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2009
• 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