MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN MALE TO MALE MINI COUPLER TRL 4MM; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Catalog Number 71933697

Device Problems Break (1069); Fracture (1260); Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2019

Event Type  malfunction  

Event Description

It was reported that during surgery the male to male coupler set for the femoral side did not allowed to thread a stem into the coupler.The procedure went fine, just an irritating step.

Manufacturer Narrative

The associated complaint device was not returned.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

Manufacturer Narrative

New additional information was received for this case.

Event Description

It was reported that during a revision surgery of non-smith and nephew devices, the male to male coupler set for the femoral side was broken and did not allow to thread a stem into the coupler.The procedure was completed using the broken device, and a back-up device was not needed.The patient was not affected.

• Brand Name: LGN MALE TO MALE MINI COUPLER TRL 4MM
• Type of Device: PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8407777
• MDR Text Key: 138375385
• Report Number: 1020279-2019-01015
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00885556064658
• UDI-Public: 00885556064658
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71933697
• Device Lot Number: 12JM00379
• Date Manufacturer Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1