MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACETABULAR LINER 36MM X 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71335754

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 11/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that revision surgery was performed due to infection.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The associated complaint devices were not returned for evaluation.

• Brand Name: R3 0 DEG XLPE ACETABULAR LINER 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6127160
• MDR Text Key: 60851482
• Report Number: 1020279-2016-00908
• Device Sequence Number: 1
• Product Code: MBL
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2023
• Device Catalogue Number: 71335754
• Device Lot Number: 13DM06454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2013
• 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: ACETABULAR SCREW, # (B)(4), LOT # 11HT09906; FEMORAL HEAD, # (B)(4), LOT # 13MM07270; MODULAR NECK, # (B)(4), LOT # 12LTM005C
• Patient Outcome(s): Hospitalization; Required Intervention