MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #6L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number 5517F601

Device Problems Fitting Problem (2183); Device Operates Differently Than Expected (2913); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2017

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock on with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that a press fit left femur had an improper fit.Surgeon re-cut and still could not get it seated.Surgeon implanted a cemented femur instead.There was a 45 minute surgical delay but no adverse consequence to patient.Rep stated no additional anesthesia was administered.

Manufacturer Narrative

An event regarding size/fit (press-fit) issue involving a triathlon femoral component was reported.The event was not confirmed.Device evaluation and results: multi directional scratches on the bearing surface of the femoral component are consistent with attempted implantation, explantation damage and subsequent post explantation/handling damage.The internal fixation surface appears unremarkable.Dimensional analysis confirms the device is within specification.Medical records received and evaluation: not performed as medical records were not provided.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there were no other similar events for the referenced lot.Conclusions: the results of the investigation indicated that the device was visually and dimensionally within specifications.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

It was reported that a press fit left femur had an improper fit.Surgeon re-cut and still could not get it seated.Surgeon implanted a cemented femur instead.There was a 45 minute surgical delay but no adverse consequence to patient.Rep stated no additional anaesthesia was administered.

• Brand Name: TRIATHLON P/A CR BEADED #6L
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6747051
• MDR Text Key: 81183996
• Report Number: 0002249697-2017-02304
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327040975
• UDI-Public: 07613327040975
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2021
• Device Catalogue Number: 5517F601
• Device Lot Number: BL66J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/27/2017
• Supplement Dates Manufacturer Received: 08/31/2017
• Supplement Dates FDA Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2016
• 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): Other