MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII CR ART INS SZ 3-4 13MM; KNEE IMPLANT

Catalog Number 71420494

Device Problems Device Slipped (1584); Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 06/11/2014

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to loosening and wear.

Manufacturer Narrative

The associated devices were returned and evaluated.A patella and an insert were returned.It was stated that the insert was removed during the patella revision.There was no communicated concerns with the insert.The lot number for the patella was not provided and could not be determined during our investigation; therefore a review of manufacturing records and lot complaint history was not possible.As a result our investigation could not determine the specific cause of the experienced failure.

• Brand Name: GII CR ART INS SZ 3-4 13MM
• Type of Device: KNEE IMPLANT
• 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: connie mcbroom ; 1450 brooks road; memphis, TN 38116 ; 9013995985
• MDR Report Key: 4108350
• MDR Text Key: 4718505
• Report Number: 1020279-2014-00578
• Device Sequence Number: 1
• Product Code: HSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71420494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: (B)(4)
• Patient Outcome(s): Required Intervention