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

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 05/24/2017

Event Type  Injury  

Event Description

It was reported that the patient suffered a fall and a subsequent dislocation of the implant's femoral head.The size of the femoral head is unknown.A closed reduction was performed in the er to resolve the adverse event without issue.

Manufacturer Narrative

"the associated complaint device was not returned.The clinical/medical team concluded, all documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation in conclusion, the clinical information provided, of the elevated metal ion levels and the black stained tissue and sac may be consistent with a reaction to metal debris.However the source cannot be determined with the available documentation.It cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The dislocation is unlikely a failure of the physical device but not enough information is available to confirm.At a 6 month follow-up the patient is reporting little pain and x-ray show the prosthesis in good position.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: UNKNOWN OXINIUM 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
• MDR Report Key: 8345296
• MDR Text Key: 136335376
• Report Number: 1020279-2019-00582
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• 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
• Date Manufacturer Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PN 71331856R3, BN (B)(4), 0 HOLE ACET SHELL 56MM; PN 71358007, BN (B)(4), REFALLPOLY 22ID58OD XLPE; PN 71331856R3, BN (B)(4), 0 HOLE ACET SHELL 56MM; PN 71358007, BN (B)(4), REFALLPOLY 22ID58OD XLPE
• Patient Outcome(s): Hospitalization; Required Intervention