MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #2 RM/LL -9MM; IMPLANT

Catalog Number 5630-G-229

Device Problems Break (1069); Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/10/2014

Event Type  malfunction  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

It was reported that 8mm#2 insert could not be inserted again and again.Then, it was broken during medical procedure.9mm #2 insert could not be inserted, so #2 tibial component was removed.And, tibia was recut and #1 tibial component was implanted instead of #2 tibial component.The surgeon controlled the gap and cutting area of bone, but it was difficult to inserted and finally inserted.

Manufacturer Narrative

An event regarding difficulty seating a triathlon pkr insert into a baseplate was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the device was not returned.-medical records received and evaluation: not performed as patient factors did not contribute to the event.-device history review: all devices accepted into final stock conformed to specification.-complaint history review: there have been no similar reported events for this lot id.Conclusions: the exact cause of the event could not be determined because the device was not returned.It was reported that this device was successfully implanted.No further investigation for this event is possible at this time.If this device is made available, this investigation will be reopened.

Event Description

It was reported that 8mm#2 insert could not be inserted again and again.Then, it was broken during medical procedure.9mm #2 insert could not be inserted, so #2 tibial component was removed.And, tibia was recut and #1 tibial component was implanted instead of #2 tibial component.The surgeon controlled the gap and cutting area of bone, but it was difficult to inserted and finally inserted.

• Brand Name: TRIATHLON PKR INSERT X3 #2 RM/LL -9MM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4303381
• MDR Text Key: 19049263
• Report Number: 0002249697-2014-04534
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 5630-G-229
• Device Lot Number: MNH3H7
• Other Device ID Number: STERILE LOT# MSGNJ02J3
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/24/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2014
• 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): Other
• Patient Weight: 63