MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 HA MULTI-HOLE ACET SHELL 58MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71338738

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Unspecified Infection (1930)

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer indicated that there is no product/device to be returned for investigation analysis.

Event Description

It was reported a procedure was performed for the removal of all total hip components due to infection.

Manufacturer Narrative

Customer indicated that there is no product/device to be returned for investigation analysis.

Manufacturer Narrative

The associated complaint devices were not returned for evaluation.

• Brand Name: R3 HA MULTI-HOLE ACET SHELL 58MM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• 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 ; 9013995009
• MDR Report Key: 6058158
• MDR Text Key: 58418601
• Report Number: 1020279-2016-00828
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2024
• Device Catalogue Number: 71338738
• Device Lot Number: 14CM08137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/12/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 71332520, 15CM17075, REFLECTION SPHERICAL HEAD SCR; 71332540, 15DT53071, REFLECTION SPHERICAL HEAD SCR; 71338696, 10AM03786, R3 XLPE ACETABULAR LINER
• Patient Outcome(s): Hospitalization; Required Intervention