MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE HA COATED ACETABULAR SHELL 50MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71332250

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 01/24/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Day one post operation, x-ray showed the cup to have moved.Patient then went on to dislocate twice requiring a revision of the cup.The femoral head was removed, liner extracted and well fixed acetabular cup removed.

Manufacturer Narrative

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

• Brand Name: R3 0 HOLE HA COATED ACETABULAR SHELL 50MM
• 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 de santis ; schachenallee 29; aarau 5001 ; SZ 5001 ; 9013995009
• MDR Report Key: 6286608
• MDR Text Key: 66059163
• Report Number: 1020279-2017-00073
• 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
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71332250
• Device Lot Number: 15FM00613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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: 71339550/15HM16739, R3 XLPE ACETABULAR LINER; 71343203/15FM09332, OXINIUM FEMORAL HEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR