MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE ACET SHELL 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71331850

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

Patient Problem Pain (1994)

Event Date 10/23/2012

Event Type  Injury  

Event Description

It was reported through a clinical study that an invasive procedure - hip punction was performed on a patient due to pain in left hip.Outcome is deemed resolved.

Manufacturer Narrative

On (b)(6) 2017 we have recevied a correction to previously reported adverse event from the study site.Here it was stated that the event occured at the contralateral hip, correcting the event reported through this mdr to a non-device related event.Further to new information received we ask you to disregard mdr 1020279-2017-00241.

• Brand Name: R3 0 HOLE ACET SHELL 50MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: milos stojkovic ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6456606
• MDR Text Key: 71613457
• Report Number: 1020279-2017-00241
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K070756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2019
• Device Catalogue Number: 71331850
• Device Lot Number: 09GM18319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2009
• 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
• Treatment: ANTHOLOGY SO POROUS SIZE 4, (B)(4); COCR 12/14 FEM HD 32 + 0, (B)(4); R3 20DEGXLPE ACETLNR 32MMX50MM, (B)(4); REF THREADED HOLE COVER, (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 113