MAUDE Adverse Event Report: SMITH AND NEPHEW INC R3 3 HOLE ACET SHELL 54MM; PRSTHSIS,HIP,SEMICONSTRAINED,UNEMNTD,MTAL/POLYMER,PORS

Catalog Number 71335554

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Swelling (2091); Toxicity (2333); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that revision surgery had been scheduled due to metallosis.

Manufacturer Narrative

Initially this complaint was submitted for a product registered under (b)(4) site; according to new information provided this event is related to a product that was manufactured in (b)(4) (manufacturing number (b)(4)) and the following fields were corrected for this mdr.

Event Description

It was reported that right hip r3 revision surgery was performed due to chronic inflammation with synovitis and possible acetabular loosening.

• Brand Name: R3 3 HOLE ACET SHELL 54MM
• Type of Device: PRSTHSIS,HIP,SEMICONSTRAINED,UNEMNTD,MTAL/POLYMER,PORS
• Manufacturer (Section D): SMITH AND NEPHEW INC; 1450 brooks road; spa park; memphis TN
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; spa park; memphis TN
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6632982
• MDR Text Key: 77275496
• Report Number: 3005975929-2017-00173
• Device Sequence Number: 1
• Product Code: MBL
• 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: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2020
• Device Catalogue Number: 71335554
• Device Lot Number: 10HM08717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2010
• 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 SHELL, PART AND LOT # UNKNOWN; FEMORAL STEM, PART AND LOT # UNKNOWN; HEMI HEAD, PART AND LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention