MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR BEADED FEM #5R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5513F502

Device Problems Disconnection (1171); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 10/06/2015

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

It is reported by the surgeon of the hospital that 1 year after initial surgery, the implant has not connected to the bone.

Manufacturer Narrative

An event regarding loosening involving a triathlon femoral component was reported.The event was confirmed.Method & results: -device evaluation and results: the returned femoral component has evidence of a very small amount fibrous tissues interfacing on the distal beaded surface.There are no clear signs of any bony fixation.The anterior tip has several dents that can be most likely attributed to damage during the explantation process.The superior condyle surfaces have some mild abrasive wear that is consistent with in vivo use.The device is otherwise unremarkable.-medical records received and evaluation: medical review indicated; interfacial bone defect conditions were created during surgical preparation while using porous beaded devices that have suboptimal property to compensate for such issues leading to device loosening requiring revision surgery.The surgeon is responsible for optimal component choice given the implantation conditions in the patient.The interfacial bone contact defect conditions are caused by surgical technique even though unavoidable given today¿s state of technology with implantation.Devices with a higher degree of surface bioactivity are available to compensate for such conditions.There are no device-related aspects here because the behavior of the devices is in line with their expected behavior as further supported by the explant pictures that confirm an almost pristine appearance including the bearing insert.This pi case is not device-related.-device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.-complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot.Conclusions: visual inspection identified a very small amount of fibrous tissues interfacing on the distal beaded surface and no clear sign of any bony fixation.Medical review indicated that interfacial bone defect conditions were created during surgical preparation while using porous beaded devices that have suboptimal property to compensate for such issues leading to device loosening requiring revision surgery.The surgeon is responsible for optimal component choice given the implantation conditions in the patient.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It is reported by the surgeon of the hospital that 1 year after initial surgery, the implant has not connected to the bone.

• Brand Name: TRIATHLON CR BEADED FEM #5R
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5196179
• MDR Text Key: 30207298
• Report Number: 0002249697-2015-03560
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 5513F502
• Device Lot Number: EJH9L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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
• Patient Outcome(s): Required Intervention