MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID INTL DLT CER LNR 58MM PROST, HIP, SEMI-CNSTRND, UNCMNTD, MET/POLY, POROUS

Catalog Number 71331758

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

Patient Problem Subluxation (4525)

Event Date 12/10/2021

Event Type  malfunction  

Manufacturer Narrative

Internal reference number: case-(b)(4).

Event Description

It was reported that, after a left thr surgery performed on the (b)(6) 2021 via posterior approach with anthology/r3 conc construct, the patient had dislocated hip at rehab post-op. The patient had a revision left thr surgery on (b)(6) 2021 to treat this adverse event. The components seemed well fixed and in appropriate position by surgeon. The patient was dislocating during flexion and ir during rom test. The biolox delta head 36 mm 12/14 s / +0 was removed with punch and the r3 36mm id intl dlt cer lnr 58mm was removed with a liner removal tool. The patient was trialed with 36mm heads and 36x58/20 degree liner trials and the hip seemed stable in rom. 20 degree xlpe liner inserted and impacted into r3 shell, and 36mm l biolox option head impacted to retained anthology stem. The hip was stable through rom. The wound was irrigated and closed in layers. The patient was not harmed beyond the reported problem.

• Brand Name: R3 36MM ID INTL DLT CER LNR 58MM
• Type of Device: PROST, HIP, SEMI-CNSTRND, UNCMNTD, MET/POLY, 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: 13111724
• MDR Text Key: 282918513
• Report Number: 1020279-2021-08952
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 71331758
• Device Lot Number: 17GT90111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 07/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 12/29/2021 Patient Sequence Number: 1