MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECH POR STD 260MM BOW SZ 13 L; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71340413
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Pain (1994); Injury (2348)
Date of Event	06/07/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a revision surgery due to breakage of femoral stem following a fall.It was reported that before the fall patient had severe pain.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please review attached for investigation results.(b)(4).
Additional Manufacturer Narrative
Corrections based on device reception and re-opening of investigation.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.Please see attached file for our results of investigation.(b)(4).

• Brand Name: ECH POR STD 260MM BOW SZ 13 L
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6770295
• Report Number: 1020279-2017-00595
• Device Sequence Number: 19175235
• Product Code: LPH
• UDI-Device Identifier: 03596010328984
• UDI-Public: 03596010328984
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K983834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/09/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/25/2021
• Device Model Number: 71340413
• Device Catalogue Number: 71340413
• Device Lot Number: 11MM14012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Initial Date Received by Manufacturer: 06/12/2017
• Supplement Date Received by Manufacturer: 06/12/2017; 06/12/2017; 06/12/2017
• Initial Report FDA Received Date: 08/07/2017
• Supplement Report FDA Received Date: 10/10/2017; 11/24/2017; 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 48 YR