MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECH POR STD 260MM BOW SZ 12 R; PRSTHESIS, KNEE,PATLLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/MTAL/POLY

Catalog Number	71340512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the right hip echelon stem broke.Stem has been replaced.
Additional Manufacturer Narrative
The affected echelon bowed porous stem was not returned for evaluation.Without the return of the actual product involved and no batch information available, our investigation of this report is inconclusive.Our clinical analysis noted that no relevant clinical medical information was provided to conduct a thorough medical assessment.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: ECH POR STD 260MM BOW SZ 12 R
• Common Device Name: PRSTHESIS, KNEE,PATLLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/MTAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8184037
• Report Number: 1020279-2018-02845
• Device Sequence Number: 16620062
• Product Code: JWH
• UDI-Device Identifier: 03596010383952
• UDI-Public: 03596010383952
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2019

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 Catalogue Number: 71340512
• Initial Date Received by Manufacturer: 11/22/2018
• Supplement Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 02/22/2019
• 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: 85 YR