MAUDE Adverse Event Report: 1818910 DEPUY ORTHOPAEDICS, INC. UNK DEPUY BONE SCREW

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 10/14/2014

Event Type  Injury  

Event Description

Patient was revised to address pain and cup loosening.Upon revision, fluid collection and metallosis were noted.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.Udi: unavailable.Depuy synthes has been informed that the catalog number and lot number is not available.

Manufacturer Narrative

Examination of the reported devices finds nothing outward to suggest product problem.A search of the complaints databases finds no other reports against the product and lot code combinations since their release to distribution.The investigation can draw no conclusion with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.

• Brand Name: UNK DEPUY BONE SCREW
• Type of Device: BONE SCREW
• 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: 4291105
• MDR Text Key: 5190820
• Report Number: 1818910-2014-33018
• Device Sequence Number: 1
• Product Code: LXH
• 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: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: No
• 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: 43 YR
• Patient Weight: 76