MAUDE Adverse Event Report: 1818910 DEPUY ORTHOPAEDICS, INC. UNKNOWN DEPUY MENISCAL BEARING

Catalog Number UNK-KNEE

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Bone Fracture(s) (1870); Osteolysis (2377)

Event Date 12/24/2013

Event Type  Injury  

Manufacturer Narrative

Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The device associated with this report was not returned.Review of the device history records and/or a lot specific complaint database search was not possible as the lot code required was not provided.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.No additional information was obtained.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 the additional information be received, the investigation will be re-opened.

Event Description

Patient was revised to address a collapsed/failed meniscal bearing which resulted in metal/metal contact generating large amounts of metallosis.Additionally, the metallosis is believed to have caused a large amount of lysis in posterior femur which eventually caused the bone to fail.Revision surgery revealed large amounts of metal debris and loosening of the femur due to a fracture.

Manufacturer Narrative

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

• Brand Name: UNKNOWN DEPUY MENISCAL BEARING
• Type of Device: MENISCAL BEARING
• Manufacturer (Section D): 1818910 DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic dr.; warsaw IN 46581
• Manufacturer (Section G): 1818910 DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic dr; warsaw IN 46581
• Manufacturer Contact: stacey trick ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714554
• MDR Report Key: 3572369
• MDR Text Key: 11423499
• Report Number: 1818910-2014-10797
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/24/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-KNEE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2014
• Initial Date FDA Received: 01/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2014
• 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: 75 YR
• Patient Weight: 66