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
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2018
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7805857
• Report Number: 1020279-2018-01586
• Device Sequence Number: 1142848
• Product Code: MBH
• UDI-Device Identifier: 03596010549198
• UDI-Public: 03596010549198
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 71434411
• Device Lot Number: 17LM05396
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 11/26/2018
• 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: Required Intervention