MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 HOLE ACETABULAR SHELL 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED

Catalog Number 71331858

Device Problem Positioning Problem (3009)

Patient Problem Joint Dislocation (2374)

Event Date 09/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the patient was dislocating due to cup position, therefore cup, liner and head were replaced in a revision surgery.

Manufacturer Narrative

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

• Brand Name: R3 0 HOLE ACETABULAR SHELL 58MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED
• 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: 5999552
• MDR Text Key: 56454585
• Report Number: 1020279-2016-00771
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P030022
• 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: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71331858
• Device Lot Number: 15HM10915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2015
• 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: (B)(4), OXINIUM FEM HD 12/14 36 MM; (B)(4), R3 XLPE ACETABULAR LINER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR