MAUDE Adverse Event Report: 3006356043 JOHNSON & JOHNSON MEDICAL PINN CAN BONE SCREW 6.5MMX30MM; HIP OTHER IMPLANT

Catalog Number 121730500

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 05/31/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient has been revised to address a wound infection.The patient's medical records were received.Medical records were reviewed for mdr reportability.According to the medical records, the patient was experiencing pain and erythema.The patient underwent a debridement of the right hip wound on (b)(6) 2016.During the procedure the surgeon noted that he could not identify any communication of the infection with the joint.Intraoperative wound cultures were consistent with staph aureus and contamination of the underlying prosthetic joint components could not be ruled out.The patient underwent a second i&d with explantation of the right total hip arthroplasty on (b)(6) 2016.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: PINN CAN BONE SCREW 6.5MMX30MM
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): 3006356043 JOHNSON & JOHNSON MEDICAL; no.299 changyang st; suzhou industrial park; suzhou 21512 -6; CH 21512-6
• Manufacturer (Section G): J3006356043 JOHNSON & JOHNSON MEDICAL; no.299 changyang st; suzhou industrial park; suzhou 21512 -6; CH 21512-6
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5797869
• MDR Text Key: 49634436
• Report Number: 1818910-2016-23232
• Device Sequence Number: 1
• Product Code: NDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2016

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: 121730500
• Device Lot Number: D15082659
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2016
• Initial Date FDA Received: 07/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2016
• 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: 57 YR
• Patient Weight: 136