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

Catalog Number 71335756

Device Problem Malposition of Device (2616)

Patient Problem Injury (2348)

Event Date 03/29/2018

Event Type  Injury  

Event Description

It was reported that the shell was put in too vertical.Doctors plan was to remove the shell and liner but when he found out the stem was a modular stem he decided to explant everything.

Manufacturer Narrative

The associated complaint devices were not returned.The clinical/medical team concluded, the x-ray provided confirmed the complaint description of the angle of the cup but without comparisons its not known if this was a migration or the implant angle.Without the explant, the requested clinical information , or the reason for the revision, a root cause for the unspecified post operative condition cannot be concluded.The future impact to the patient beyond the revision cannot be concluded.No further clinical/medical assessment is warranted at this time.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: R3 20 DEG XLPE ACET LNR 36MM X 56MM
• 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: sarah freestone ; 101 hessle road; hull HU3 2-BN ; UK HU3 2BN
• MDR Report Key: 7451989
• MDR Text Key: 106208994
• Report Number: 1020279-2018-00798
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598356
• UDI-Public: 03596010598356
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71335756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR