MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HD 26 + 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 71302600

Device Problems Fracture (1260); Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 02/28/2017

Event Type  Injury  

Event Description

It was reported that during the primary surgery, patient's leg bone was fractured.After surgery the patient fell due to leg length discrepancy and a revision surgery had to be performed.The surgeon decided it was not a product complaint.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during the primary surgery, patient's leg bone was fractured.After surgery the patient fell, causing leg length discrepancy which required a revision surgery.The surgeon decided it was not a product complaint.

• Brand Name: COCR 12/14 FEM HD 26 + 0
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 6398607
• MDR Text Key: 69750287
• Report Number: 1020279-2017-00173
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K963509
• 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: 09/06/2017

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: 71302600
• Device Catalogue Number: 71302600
• Device Lot Number: 16JM17285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/13/2017
• Supplement Dates Manufacturer Received: 03/01/2017
• Supplement Dates FDA Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2016
• 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: 71305412, LOT: 16LM11394, SYN SEL II POR SO 10/12; 71325048, LOT: 16GM05078, TNDM BP SHL/XLPE LNR 48O
• Patient Outcome(s): Hospitalization; Required Intervention