MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71335754

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 10/24/2018

Event Type  Injury  

Event Description

It was reported that the patient had a replacement on (b)(6) 2018.His hip became painful and red and inflamed on (b)(6) 2018, so on (b)(6) 2018 the doctor opened the wound for debridement and to place antibiotic granules in die wound, he decided to change the poly and femur head.

Manufacturer Narrative

The associated complaint devices were not returned.Without the actual product involved our investigation cannot proceed.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The medical investigation concluded that without supporting clinical/medical documents a thorough investigation could not be performed.Should information become available this complaint can be re-assessed.If the devices or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: R3 20 DEG XLPE ACET LNR 36MM X 54MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8075256
• MDR Text Key: 127286068
• Report Number: 1020279-2018-02501
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598349
• UDI-Public: 03596010598349
• Combination Product (y/n): N
• PMA/PMN Number: K113848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71335754
• Device Lot Number: 17MM11336
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention