MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 52MM; PRSTHSIS,HIP,SEMICNSTRND,UNCMNTD,METALPOLYMER,POROUS

Catalog Number 71335552

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 10/10/2017

Event Type  Injury  

Event Description

It was reported that implants were removed due to infection.

Manufacturer Narrative

The associated complaint device was not returned for evaluation.Please see the attached file for the results of our investigation.(b)(4).

• Brand Name: R3 3 HOLE ACET SHELL 52MM
• Type of Device: PRSTHSIS,HIP,SEMICNSTRND,UNCMNTD,METALPOLYMER,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: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 6985349
• MDR Text Key: 90503846
• Report Number: 1020279-2017-00936
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598240
• UDI-Public: 03596010598240
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71335552
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 10/27/2017
• Supplement Dates Manufacturer Received: 10/10/2017
• Supplement Dates FDA Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Hospitalization; Other