MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER

Catalog Number 71335554

Device Problem Detachment Of Device Component (1104)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 03/28/2017

Event Type  Injury  

Event Description

Revision surgery was performed because the patient has had pain and evidence of cup migration according to x-ray.

Manufacturer Narrative

(b)(4).

• Brand Name: R3 3 HOLE ACET SHELL 54MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER
• 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: yagna angirish ; 1450 brooks rd; memphis, TN 38116
• MDR Report Key: 6500207
• MDR Text Key: 73024388
• Report Number: 1020279-2017-00275
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598257
• UDI-Public: 03596010598257
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 71335554
• Device Lot Number: 14AM01276
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2014
• 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: PART#71332754 LOT#14AM02143 R3 XLPE LINER; PART#71343608 LOT#13FM149083 OXINIUM FEM HEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR