MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JII XR TIBIA POSTERIOR KEEL PUNCH SZ 3-4; PROSTH,KNEE,PATFEMOTIAL,SEM-CONSTED,CEMNTED,POLY/METAL/POLY

Catalog Number	74013987
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	06/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during keel preparation with new xr punch the proximal medial tibia fractured.This is a late report due to the event was reported to the complaint's department after 30 days of aware by the company sales representative.
Additional Manufacturer Narrative
The associated journey ii xr tibia posterior keel punch was not returned for evaluation.A clinical evaluation noted that the reported tibial fracture was confirmed by the provided photo.The root cause cannot be concluded; however the product design cannot be excluded as a possible contributing factor to the reported event.The patient impact beyond the reported tibial fracture, possible extended hospitalization and rehab/convalescence period cannot be determined.Our investigation noted that this failure has been previously identified.This issue has been elevated to our risk assessment process.Our investigation indicated that the related device was part of field action initiated in 2018.Corrective actions have been initiated.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.
Additional Manufacturer Narrative
The associated journey ii xr tibia posterior keel punch was not returned for evaluation.This complaint was reopened due to receipt of new information related to the follow-up status of the patient at 3 months.After reviewing medical notes, the clinical analysis noted that patient sustained an incidental fall that was unrelated.Per the email communication received the patient is doing fine.No further assessment is required.Our investigation indicated that the related device was part of field action initiated in 2018.Corrective actions have been initiated.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JII XR TIBIA POSTERIOR KEEL PUNCH SZ 3-4
• Common Device Name: PROSTH,KNEE,PATFEMOTIAL,SEM-CONSTED,CEMNTED,POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7721157
• Report Number: 1020279-2018-01423
• Device Sequence Number: 13713214
• Product Code: JWH
• UDI-Device Identifier: 00885556696026
• UDI-Public: 00885556696026
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/05/2019

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: 74013987
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 06/18/2018; 06/18/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 01/14/2019; 04/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: R-2018-39
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR