MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE ACET SHELL 52MM; REF. 3 ACETABULAR SYSTEM

Catalog Number 71331852

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Dislocation (2374)

Event Date 03/31/2016

Event Type  Injury  

Manufacturer Narrative

Udi# (b)(4).Customer indicated that there is no product/device to be returned for investigation analysis.

Event Description

It was reported a revision surgery was performed due to implant dislocation.

• Brand Name: R3 0 HOLE ACET SHELL 52MM
• Type of Device: REF. 3 ACETABULAR SYSTEM
• 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 ; 9013995009
• MDR Report Key: 5541580
• MDR Text Key: 41664450
• Report Number: 1020279-2016-00275
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• 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: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2023
• Device Catalogue Number: 71331852
• Device Lot Number: 13EM20275
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2013
• 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: 71336500/14DM12337
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR