MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 71335756

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

Patient Problems Joint Dislocation (2374); Joint Laxity (4526)

Event Date 02/23/2024

Event Type  Injury  

Event Description

It was reported that, after a thr surgery had been performed on (b)(6) 2022, the patient experienced instability and multiple dislocations.This adverse event was solved by a revision surgery on (b)(6) 2024, in which a r3 20 deg xlpe acet lnr 36mm x 56mm and a cocr 12/14 fem head 36mm +12 were exchanged.Despite these interventions, sufficient stability was not achieved.However, after exchanging a cpcs cocr prim so 12/14 sz 3 for a higher offset, smaller-sized stem, length, and stability improved, resulting in a stable hip joint.The current health status of the patient is recovering well.

Manufacturer Narrative

Internal complaint reference (b)(4).

• Brand Name: R3 20 DEG XLPE ACET LNR 36MM X 56MM
• 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: 18952102
• MDR Text Key: 338266558
• Report Number: 1020279-2024-00580
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010598356
• UDI-Public: 03596010598356
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71335756
• Device Lot Number: 22CM05930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2022
• 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): Hospitalization; Required Intervention