MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM M/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER

Model Number 71343604

Device Problem Detachment Of Device Component (1104)

Patient Problem Fall (1848)

Event Date 05/30/2017

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 required due to patient early fall and dislocation followed by recurrent dislocation.

Manufacturer Narrative

The devices related to this complaint were not returned.Please see the attached file to check our investigation results.(b)(4).

• Brand Name: OXINIUM FEM HD 12/14 36 MM M/+4
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER
• 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: yagna angirish ; 1450 brooks rd; memphis, TN 38116
• MDR Report Key: 6658003
• MDR Text Key: 78099163
• Report Number: 1020279-2017-00464
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010477286
• UDI-Public: 03596010477286
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K022958
• 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: 10/05/2017

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 Model Number: 71343604
• Device Catalogue Number: 71343604
• Device Lot Number: 16KM17103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2017
• Initial Date FDA Received: 06/21/2017
• Supplement Dates Manufacturer Received: 05/30/2017
• Supplement Dates FDA Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2016
• 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: 71312363 / 15FM22194, CPCS COCR PRIM SO 12/14 SZ 3; 71312412 / 16HM03552, CPCS DIST CENT SZ 12MM; 71331952 / 16MM00780, R3 3 HOLE HA CTD ACET SHELL
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR