MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 HA MULTI-HOLE ACET SHELL 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71338739

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

Patient Problem Unspecified Infection (1930)

Event Date 08/14/2017

Event Type  Injury  

Event Description

It was reported that, after a right thr revision surgery had been performed on (b)(6) 2017 with adverse soft tissue reaction to particulate debris as primary diagnosis, the patient experienced an additional unspecified infection that made necessary a second revision surgery on (b)(6) 2017.During this procedure, the acetabular cup and femoral head were explanted.According to the report contents, the femoral head was replaced with a smith and nephew cobalt-chrome 32mm femoral head.This information was provided by (b)(6) 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.

Manufacturer Narrative

Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through a review of (b)(6) 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.

• Brand Name: R3 HA MULTI-HOLE ACET SHELL 60MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• 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: 16284956
• MDR Text Key: 308653568
• Report Number: 1020279-2023-00235
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K201701
• 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: 02/02/2023

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 Expiration Date: 09/07/2020
• Device Catalogue Number: 71338739
• Device Lot Number: 10JM03265
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/31/2023
• Initial Date FDA Received: 02/02/2023
• Date Device Manufactured: 09/07/2010
• 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: 71337660 / LOT: 16FM15227.; PN: 71343208 / LOT: 15FM14967A.; PN: 75100476 / LOT: B1700719.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male