MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN AP FEM CUTTING BLK SZ 6; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 71434411

Device Problem Component Missing (2306)

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

Event Date 08/01/2018

Event Type  Injury  

Event Description

It was reported a medical intervention due to ball bearings falling out of the device.One recovered, one lost.Had to xray the patient to ensure missing piece was not inside the wound.Piece was not into patient bu never located.

Manufacturer Narrative

The associated complaint device was returned and evaluated.Our assessment confirmed one the ball bearings is disconnected from the cutting block and one has not been returned.The device shows moderate signs of wear/usage.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.The clinical/medical team concluded, based on the report that radiological imaging verified that the ¿ball bearing¿ was not in the patient, there are no biocompatibility concerns.No surgical delay or patient injury/harm was reported.It was not reported if the femoral cutting block was able to be used prior to the ball bearing falling out or if they had to complete the procedure with an alternative device? the patient impact beyond the additional radiography cannot be determined based on the limited information provided.No further medical assessment can be rendered at this time.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, qh (b)(4) was issued for corrective action.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: LGN AP FEM CUTTING BLK SZ 6
• 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: sarah freestone ; 101 hessle road; hull HU3 2-BN ; UK HU3 2BN
• MDR Report Key: 7805857
• MDR Text Key: 117890473
• Report Number: 1020279-2018-01586
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 03596010549198
• UDI-Public: 03596010549198
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/26/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 71434411
• Device Lot Number: 17LM05396
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/22/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2017
• 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
• Patient Outcome(s): Required Intervention