MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 MULTI HOLE ACETABULAR SHELL 54MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71338666

Device Problem Malposition of Device (2616)

Patient Problems Deformity/ Disfigurement (2360); Joint Dislocation (2374)

Event Date 01/06/2021

Event Type  Injury  

Event Description

It was reported that, after a tha had been performed, the patient experienced two dislocations that requiered relocation of the joint. For the third dislocation therefore patient had to be taken to the or. A revision surgery was performed to treat this event. The synergy stem was well fixed, but the surgeon felt like the r3 multi hole acetabular shell 54mm was malpositioned; therefore, it was removed. The r3 20 deg xlpe acet lnr 36mm x 58mm and cocr 12/14 fem head 36mm +0 were also removed. The surgeon repositioned the cup and implanted a redapt modular cup with or30 assembly, acetabular screws and 28mm oxinium head. Patient outcome is unknown.

• Brand Name: R3 MULTI HOLE ACETABULAR SHELL 54MM
• 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: 11250218
• MDR Text Key: 229293151
• Report Number: 1020279-2021-00761
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 71338666
• Device Catalogue Number: 71338666
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/29/2021 Patient Sequence Number: 1

Treatment

COCR 12/14 FEM HEAD 36MM +0; R3 20 DEG XLPE ACET LNR 36MM X 58MM