MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GENESISII MIS DCF AP CUTTING BLOCK SIZE 7; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 71441155

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 09/08/2016

Event Type  Injury  

Event Description

It was reported to us that surgeon was performing a legion primary total knee arthroplasty during which it was noticed that the posterior cut had taken off more bone than anticipated using cutting block size 7, and subsequently after cutting with cutting block size 6 that approximate 2mm gap between the posterior cut and the posterior internal aspect of the femoral trial was discovered.The surgeon successfully finished the procedure implanting the components of different configuration then planned.Surgical procedure time was extended 45 minutes.

• Brand Name: GENESISII MIS DCF AP CUTTING BLOCK SIZE 7
• 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: 5979849
• MDR Text Key: 55710025
• Report Number: 1020279-2016-00752
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Relabeling
• Type of Report: Initial,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71441155
• Device Lot Number: 12BM10390
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2016
• 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: GII CUTT. BLOCK SZ6, PART#:71441154,LOT#:09CM23965
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR