MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71332752

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 07/19/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that the surgeon does believes this to be the product failure because it has taken long time after the primary surgery.

Event Description

It was report that patient underwent a revision surgery with exchange of femoral head and acetabular liner due to infection.

Manufacturer Narrative

The associated complaint device was not returned for evaluation.[(b)(4)].

• Brand Name: R3 0 DEG XLPE ACET LNR 36MM X 52MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 05001 ; SZ 05001
• MDR Report Key: 6773041
• MDR Text Key: 82005775
• Report Number: 1020279-2017-00602
• Device Sequence Number: 1
• Product Code: MBL
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 71332752
• Device Lot Number: 16DM10458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2016
• 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: OXINIUM FEMORAL HEAD, PART & LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention