MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN R3 LINER CERAMIC POLY; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

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

Patient Problem Unspecified Infection (1930)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on literature review ¿acetabular liner dissociation: a comparative study of two contemporary uncemented acetabular components¿, one deep infection was reported causing revision surgery, the liner and the femoral head were exchanged.

Manufacturer Narrative

Event date: (b)(6) 2020.

Manufacturer Narrative

Documents added to the attachments page.

Manufacturer Narrative

The device, used for treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms the data presented in the article refers to a patient who required a liner and head revision for ¿early deep infection¿.However, patient specific medical documentation has not been provided as of the date of this review.Based on the information provided, the root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded.Per author/associate professor correspondence, no further details or implants are available and ¿dislocations, periprosthetic fractures and deep infections happen.The rate in this series is low and is not in my view related to the implants used.¿ no further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-opened for further evaluation.Infection, a potential complication associated with any surgery, can occur and possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.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: UNKNOWN R3 LINER CERAMIC POLY
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11157675
• MDR Text Key: 226537676
• Report Number: 1020279-2021-00303
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention