MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 60MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71335560

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

Patient Problems Joint Dislocation (2374); Metal Related Pathology (4530)

Event Date 09/10/2015

Event Type  Injury  

Event Description

It was reported that, after a first revision surgery had been performed on plaintiff's left hip on (b)(6) 2014, the plaintiff chronic recurrent dislocations that led to a second revision surgery, which was performed on (b)(6) 2015 to treat the adverse event. The liner, the cup, and the femoral head were replaced. The plaintiff's outcome is unknown.

• Brand Name: R3 3 HOLE ACET SHELL 60MM
• 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: 12370929
• MDR Text Key: 268253914
• Report Number: 1020279-2021-06536
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070756
• 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: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/12/2018
• Device Model Number: 71335560
• Device Catalogue Number: 71335560
• Device Lot Number: 08MM11547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/06/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 12/14/2008
• 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: 08/26/2021 Patient Sequence Number: 1