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

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Joint Dislocation (2374)

Event Date 07/09/2018

Event Type  Injury  

Event Description

It was reported that patient had a primary left total hip replacement over twenty years ago.Recently dislocated hip, revision operation performed on soft tissue around capsule.Removed for histology, surgeon stated that it was evidence of poly wear.Hip exposed stem found to be solidly fixed, femoral head removed.Poly liner removed as well.Evidence of the macroscopic wear on the femoral head and the lop of the poly has been worn away.

Manufacturer Narrative

The associated complaint devices were not returned.A clinical evaluation was conducted after a review of the complaint details provided; there were no abnormal finding that would suggest a deficiency in the product.In addition, neither the explant nor supporting clinical document was provided for inclusion in this investigation.Should any clinical documents be provided this case would be re-evaluated.No further clinical/medical assessment is warranted at this time.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: FEMORAL HEAD
• 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: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0110447940
• MDR Report Key: 7729045
• MDR Text Key: 115344002
• Report Number: 1020279-2018-01442
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention
• Patient Age: 88 YR