MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MIS DCF AP CT BLK 4; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71441152
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after procedure tka the surgeon did not notice the missing peg from the cutting block until postoperative x-ray (during the procedure the surgeon followed proper technique in placement and removal of the 4 in 1 cutting block).The procedure was completed without delay.
Additional Manufacturer Narrative
Additional information based on the results of the investigation indicates that this complaint should be reassessed in terms of reportability.The new information reveals that the device corresponding to this complaint belongs to a different set of devices than the one initially reported and also does not present any failure related to the reported event.

• Brand Name: GII MIS DCF AP CT BLK 4
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10176726
• Report Number: 1020279-2020-02623
• Device Sequence Number: 16682699
• Product Code: HRY
• UDI-Device Identifier: 03596010497208
• UDI-Public: 03596010497208
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2021

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 Model Number: 71441152
• Device Catalogue Number: 71441152
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/30/2021
• 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: Hospitalization; Required Intervention