MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM +8; PROSTH, HIP, SEMI-CONSTRAINED, MET/CER/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number 71342808

Device Problem Biocompatibility (2886)

Patient Problem Foreign Body Reaction (1868)

Event Date 07/14/2016

Event Type  Injury  

Event Description

It was reported that, after a right thr index surgery performed on (b)(6) 2016 to address osteoarthritis symptoms, the patient experienced an unspecified adverse soft tissue reaction to particulate debris that made necessary a revision surgery on (b)(6) 2016.During this procedure, the femoral head was explanted and replaced with smith and nephew component.This information was provided by the national joint registry of the united kingdom, as part of a retrospective data collection of patients who underwent a primary thr surgery with a hip prosthesis construct that included a polarstem and that required a revision surgery due to specific reasons.As such, no further information will be available.

Manufacturer Narrative

This complaint was opened by smith+nephew to document a patient complication identified through a review of the national joint registry from united kingdom that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.Internal complaint reference number: (b)(4).

• Brand Name: OXINIUM FEM HD 12/14 28MM +8
• Type of Device: PROSTH, HIP, SEMI-CONSTRAINED, MET/CER/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15801678
• MDR Text Key: 303700510
• Report Number: 1020279-2022-04794
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010474179
• UDI-Public: 03596010474179
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K021673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2022

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 Model Number: 71342808
• Device Catalogue Number: 71342808
• Device Lot Number: 15EM18779
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/28/2015
• 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
• Treatment: PN: 71332254/ LN: 16AM19821; PN: 71334954/ LN: 16AM03845; PN: 75100466/ LN: B1604325
• Patient Outcome(s): Required Intervention
• Patient Age: 70
• Patient Sex: Male
• Patient Weight: 117 KG