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

Catalog Number 621322

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/22/2011

Event Type  Injury  

Event Description

Patient of (b)(4) received knee-tep left side (unknown manufacturer) in 2002.Patient slipped out on ice snow.Fall and distortion of left knee.Fracture of femur, osteosynthesis with help of plate.Since this malposition, pain because of loosening and osteolysis.Because of this he got implantation of new knee prothesis on (b)(6) 2007.On (b)(6) 2011 revision of parts of the 2007 construct and implantation of new tibial components because of loosening and patella (unknown manufacturer - date of first patella implantation seems to be 2002) because of wear.

Manufacturer Narrative

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

The devices associated with this report were not returned for evaluation.Patient medical records and x-rays were provided for review.Review of the supplied investigational inputs confirmed osteolytic bone, loosening of the tibial component, and wear on the patellar component.With the information provided, it cannot be determined that the complaint is product related.The implant loosening was likely a result of the patient¿s poor bone quality.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, 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): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4041952
• MDR Text Key: 4863415
• Report Number: 1818910-2014-26799
• 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: 07/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 621322
• Device Lot Number: 4961322B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 61 YR
• Patient Weight: 95