MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC KINCISE REPL CAP HEAD ADAPTER FEMORAL; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 1013-00-901

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/05/2019

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).Device manufacture date: the device manufacture date is unavailable concomitant medical products and therapy dates: tc3 sleeve, vice grip, slap hammer device, (b)(6) 2019.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported that while the surgeon was attempting to take out a tc3 knee revision, it was discovered that the tibia was loose.The reporter stated that it was not anticipated that the femur was loose.However, when the femur was pushed on, it was observed that the femur was loose.It was further reported that the sleeve was well fixated but seemed the cement mantle failed.According to the reporter, the tibia was a ¿sz 3 fb modular+ tray¿ and the femur was a ¿sz 4 tc3¿ femur with a sleeve and stem.The reporter indicated that it took close to an hour to take out the implants.The reporter clarified that there was no surgical delay because it normally took that time duration to remove revision implants, especially those with a sleeve.The reporter stated that it was so difficult, that the user attempted to slap out the femoral component and sleeve with an impactor device.It was reported that the impactor device was damaged and broken.It was reported that the bolt/adapter broke from the tc3 sleeve taper and the sleeve stayed in the knee.The reporter stated that a vice grip and slap hammer were used to remove the sleeve.It was reported that all the broken components were removed.There was patient involvement reported.It was reported that there were no adverse consequences to the patient.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device manufacture date: the device manufacture date was unknown in the initial report.The device manufacture date has been updated as 12/4/2018.Device evaluation: the actual device was returned for evaluation.Quality engineering evaluated the device.A visual and functional assessment was performed on the polymeric cap which found that it was dented as a result of attempting to slap out the femoral component and sleeve with the kincise head impactor which was damaged (user error).Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to device use, which is user error.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: KINCISE REPL CAP HEAD ADAPTER FEMORAL
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 8668106
• MDR Text Key: 146970288
• Report Number: 1045834-2019-53722
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1013-00-901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention