MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR HO FEM COM SZ 14; FEMORAL COMPONENT

Catalog Number 71306114

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Erythema (1840); Fatigue (1849); Itching Sensation (1943); Rash (2033)

Event Date 04/01/2008

Event Type  Injury  

Manufacturer Narrative

Udi no: (b)(4).Customer indicated that there is no product/device to be returned for investigation analysis due to no indication that the implant was explanted.

Event Description

It was reported that one year following a left hip replacement surgery, the patient developed the following symptoms: red itchy rashes on her skin, face, inner thigh, neck, back, trunk, and near the incision site; fatigue; shortness of breath.The patient has used topical creams but only help to lighten the skin temporarily.

Manufacturer Narrative

The associated complaint devices were not returned.A review of manufacturing records did not reveal any deviations that could have contributed to this issue.Without the actual products involved, our investigation cannot proceed.If the devices or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: SYN POR HO FEM COM SZ 14
• Type of Device: FEMORAL COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: robert rust ; 1450 brooks road; memphis, TN 38116 ; 9013991624
• MDR Report Key: 5186440
• MDR Text Key: 29783081
• Report Number: 1020279-2015-00754
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K963509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/19/2015

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 Expiration Date: 02/13/2017
• Device Catalogue Number: 71306114
• Device Lot Number: 07BM09546
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2015
• Initial Date FDA Received: 10/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2007
• 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): Other