MAUDE Adverse Event Report: 1818910 DEPUY ORTHOPAEDICS, INC. SROM* BASE TIB MOD UNTEXT LRG; KNEE TIBIAL TRAY

Catalog Number 621323

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Synovitis (2094)

Event Date 05/30/2014

Event Type  Injury  

Event Description

Implantation of s-rom noiles knee in 2007.Instability since (b)(6) 2014.Revision (b)(6) 2014.During revision pin breakage at femur became obvious.Explantation of complete construct.Review of medical records confirm reason for revision as - fracturing of the central axis of the s-rom femoral prosthesis in the patient's right knee with loosening of the femoral condyle and the tibial prosthesis - km (b)(6) 2014.

Manufacturer Narrative

(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Examination of the submitted srom nrhfem w/pin med rt 71x66 confirmed the reported fracture.The stem of the femoral component was fractured as a result of low stress high cycle fatigue crack initiation and propagation.No material defects were observed that could have contributed to fracture initiation and/or propagation to failure.There was no evidence of bone ingrowth into the porous coating of the implant and it fractured as a result of low stress high cycle fatigue crack initiation and propagation.It is not known to what extent the patient¿s history of peripheral vascular disease, obesity and smoking contributed to the complaint ¿ these could inhibit bone growth and the lack of fixation could result in the implant fatique and fracture.No evidence was found suggesting product error was a contributing factor and the need for corrective action was not indicated.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.

• Type of Device: KNEE TIBIAL TRAY
• Manufacturer (Section D): 1818910 DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): 1818910 DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4191810
• MDR Text Key: 4985580
• Report Number: 1818910-2014-30381
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK896048
• 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: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 621323
• Device Lot Number: 5261323A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2007
• 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: 60 YR
• Patient Weight: 115