MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 38MM ID US COCR LNR 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71341150

Device Problems Break (1069); Device Slipped (1584); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 11/08/2015

Event Type  Injury  

Manufacturer Narrative

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 loosening and broken screw.

Manufacturer Narrative

The associated complaint device was not returned.A visual inspection of the product could not confirm the stated failure without obtaining the actual device/ product.Without the actual product involved and/or device information, our investigation cannot proceed.This case reports a female in her 80¿s underwent a rs3 s&n hip implant in 2009 and required a revision in 2015 for cup loosening and a broken screw.It is reported that the operative note mentioned metallosis and osteolysis.However, no clinical relevant information was provided to conduct a thorough analysis of the reported issue.No medical investigation can be performed at this time.This case can be re-evaluated upon receiving relevant clinical documents and/or if the device or new information is received in the future.No further actions are being taken at this time.

Event Description

It was reported that during the revision surgery, osteolysis and metallosis were present.

Manufacturer Narrative

Following receipt of additional information it has been confirmed that the devices involved in this incident were metal on metal, therefore the correct manufacturing registered site code for this mdr should be (b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: R3 38MM ID US COCR LNR 50MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa TN CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa TN CV31 3HL; UK CV31 3HL
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau, TN 05001 ; SZ 05001 ; 9013995009
• MDR Report Key: 5493689
• MDR Text Key: 40114941
• Report Number: 1020279-2016-00220
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• 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,Followup
• Report Date: 01/11/2018

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 Expiration Date: 12/31/2018
• Device Catalogue Number: 71341150
• Device Lot Number: 08MW20414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/26/2016
• Initial Date FDA Received: 03/10/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 02/26/2016
• Supplement Dates FDA Received: 08/01/2016; 06/02/2017; 01/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2008
• 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; Required Intervention
• Patient Age: 84 YR