MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN R3 LINER CERAMIC POLY; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number UNKNOWN

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).Section h3, h6: this complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from literature sources 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.Shichman, i., somerville, l., lutes, w.B., jones, s.A., mccalden, r., & schwarzkopf, r.(2022).Outcomes of novel 3d-printed fully porous titanium cup and a cemented highly cross-linked polyethylene liner in complex and revision total hip arthroplasty.Arthroplasty, 4(1), 1-8.Doi: https://doi.Org/10.1186/s42836-022-00152-5.The reported events within the enclosed publication took place in several countries: united states, canada and united kingdom.A communication has been sent to the author to gather additional information on the occurrence and location of each event.However, at this time, we have not received a response from the corresponding author.Therefore, this report is being conservatively submitted as we cannot rule out the possibility that the event occurred in the united states.The occurrence date of the specifics event is unknown but it is mentioned in the literature that patients who had undergone ctha and rtha in which the acetabular component was revised with a novel titanium fully porous shell into which a new xlpe liner was cemented between january 2016 to november 2018 at four large institutions and were followed up for a mean time of was 2.21 ± 0.77 years.

Event Description

It was reported that on literature review outcomes of novel 3d-printed fully porous titanium cup and a cemented highly cross-linked polyethylene liner in complex and revision total hip arthroplasty, two (2) patients had a periprosthetic joint infection after a revision total hip arthroplasty procedure using a redapt fully porous multi-hole titanium cup with variable angle locking screws and xlpe liner from smith and nephew.The events were resolved by debridement, antibiotics, and implant retention in which the xlpe liner and femoral head were exchanged.No further information is available.

• Brand Name: UNKN R3 LINER CERAMIC POLY
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• 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: 17804658
• MDR Text Key: 324110751
• Report Number: 1020279-2023-01829
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2023
• 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
• Patient Outcome(s): Other; Hospitalization