MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM M/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 71343604

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/13/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case(b)(4).This complaint was opened by smith+nephew to document a patient complication identified through a review of the national joint registry of england, wales, northern ireland and the isle of man (njrew) 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.

Event Description

It was reported that, after undergoing a left thr revision surgery (b)(6) 2016 due to adverse soft tissue reaction to particulate debris, the patient experienced another adverse soft tissue reaction to particulate debris that made necessary a second revision surgery on (b)(6) 2020.During this procedure, all the femoral head, acetabular cup and acetabular liner were explanted.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 first thr revision surgery with a hip prosthesis construct that included a polarstem femoral prosthesis and that required a second revision surgery due to specific reasons.As such, no further information will be available.

• Brand Name: OXINIUM FEM HD 12/14 36 MM M/+4
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 16285898
• MDR Text Key: 308664782
• Report Number: 1020279-2023-00238
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010477286
• UDI-Public: 03596010477286
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K022958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71343604
• Device Catalogue Number: 71343604
• Device Lot Number: 15LM03875
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2015
• 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: 71331956 / LOT: 14CM12634.; PN: 71332756 / LOT: 14AM02161.; PN: 75100476 / LOT: B1514185.
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 65 YR
• Patient Sex: Female