MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71352117

Device Problem Corroded (1131)

Patient Problem Injury (2348)

Event Date 02/13/2017

Event Type  Injury  

Event Description

It was reported a right hip revision surgery was performed.

Manufacturer Narrative

The associated complaint device was not returned for evaluation.

Manufacturer Narrative

The associated complaint devices were returned and evaluated.A lab analysis conducted in this investigation concluded that the femoral stem implant was received assembled with the modular neck.Therefore no analysis of the modular connection was performed.From the analysis conducted in this investigation, evidence of bone on-growth and damage were observed on the stem.This damage can likely be attributed to instrument damage.Metal transfer was observed on both the articular surface of the ceramic femoral head as well as on the chamfered surface near the taper.A clinical evaluation noted based on the available information, the elevated metal ion levels, the observations in the intra-operative reports and the pain and discomfort experienced by the patient are consistent with a reaction to metal debris and the report of trunnionosis.At a follow up visit, an aspiration of fluid around the joints was sent for cultures.This did not produce any growth and was suspected to be a post-operative seroma.No further, updates on the patient¿s current status have been provided.Our investigation indicated that the associated parts in this complaint were part of field action initiated in 2016.Corrective actions have been initiated.No additional actions are being taken at this time.If additional information is received in the future, this complaint will be reopened.We consider this investigation closed.

• Brand Name: UNKNOWN
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• 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
• MDR Report Key: 6609083
• MDR Text Key: 76562980
• Report Number: 1020279-2017-00391
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/14/2019
• Device Catalogue Number: 71352117
• Device Lot Number: 09GTM0007B
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: REF. R2016-48
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR