MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN OFFSET COUPLER TRIAL 2MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 71434302

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during surgery it was discovered that 2 coupler trials were missing the locking screws and that this issue caused a clinically significant surgical delay.No other adverse patient outcome has been reported.

Manufacturer Narrative

Corrections according to new data received.

• Brand Name: LGN OFFSET COUPLER TRIAL 2MM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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 odoy ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6101853
• MDR Text Key: 59860148
• Report Number: 1020279-2016-00880
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121393
• 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
• Report Date: 11/02/2016

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 Catalogue Number: 71434302
• Device Lot Number: 08MM09117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 11/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/11/2017; 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: LGN OFFSET COUPLER TRIAL SZ UNKNOWN, PART&LOT#UNK
• Patient Outcome(s): Other