MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number 71335556

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Dislocation (2374); No Known Impact Or Consequence To Patient (2692)

Event Date 09/24/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to us through clinical trial that a patient had underwent a noninvasive procedure - closed reduction due to dislocation of the left hip.Study investigator deemed its severity as mild and its outcome as resolved.

Event Description

Per surgical report the patient states that he was sitting on bench and must have turned the wrong way.

• Brand Name: R3 3 HOLE ACET SHELL 56MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• 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 ; 0628320660
• MDR Report Key: 6331467
• MDR Text Key: 67478666
• Report Number: 1020279-2017-00103
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71335556
• Device Lot Number: 11DM13782
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 40MM OXINIUM MODULAR HEAD,PART#71342340,LOT#UNK; R3 0DEGXLPE ACETLNR40IDX56OD,PART#71338679,LOT#UNK; SYN POR HO FEM COM SZ 12,PART#71306112,LOT#UNK; TITAN. MOD. HEAD SLEEVE+4MMM,PART#71344248,LOT#UNK
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 109