MAUDE Adverse Event Report: RAYNHAM PINN CAN BONE SCREW 6.5MMX15MM; HIP OTHER IMPLANT: SCREW

Catalog Number 121715500

Device Problem Loss of Osseointegration (2408)

Patient Problem No Information (3190)

Event Date 02/18/2013

Event Type  Injury  

Event Description

Patient was revised to address pain.Update rec'd 8/12/2014 - litigation papers received.In addition to what was previously reported, litigation alleges the patient suffers from discomfort, inflammation, loosening, dislocation, pulmonary embolism as a result of a blood clot, and limited mobility.There is no new additional information that would affect the outcome of the investigation update 12/1/2014- pfs and medical records received.Pfs also alleges high metal ions and malpositioned cup.After review of the medical records for mdr reportability, the revision operative note indicated loose cup that had migrated medially, alval reaction, metallosis, and slight performation of the medial wall of the acetabulum.The stem is being added for the alleged high metal ions.There was no mention of dislocation.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: 12/29/2014.

Manufacturer Narrative

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

• Brand Name: PINN CAN BONE SCREW 6.5MMX15MM
• Type of Device: HIP OTHER IMPLANT: SCREW
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4366889
• MDR Text Key: 5114647
• Report Number: 1818910-2014-35245
• Device Sequence Number: 1
• Product Code: NDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/01/2014

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: Physician
• Device Catalogue Number: 121715500
• Device Lot Number: 441268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2014
• Initial Date FDA Received: 12/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2010
• 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: 52 YR
• Patient Weight: 108