MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #2 LM/RL -8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 5630-G-208

Device Problems Device Abrasion From Instrument Or Another Object (1387); Failure to Align (2522); Material Integrity Problem (2978); Scratched Material (3020)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/14/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Dr (b)(6).Had a very difficult time implanting the insert (5610-f-208) in a partial knee replacement.He tried several attempts, he made sure there was no soft tissue interfering with the insert seating.Eventually he decided to open a second insert and the new one seated right away with no challenges.

Manufacturer Narrative

An event regarding difficulty seating a triathlon pkr insert was reported.The event was confirmed.Method & results: -device evaluation and results: the locking features were returned damaged, confirming the event.-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 investigation concluded that damage is likely caused by misaligning the insert with the baseplate during implantation.

Event Description

Dr (b)(6).Had a very difficult time implanting the insert (5610-f-208) in a partial knee replacement.He tried several attempts, he made sure there was no soft tissue interfering with the insert seating.Eventually he decided to open a second insert and the new one seated right away with no challenges.

• Brand Name: TRIATHLON PKR INSERT X3 #2 LM/RL -8MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5209622
• MDR Text Key: 31017335
• Report Number: 0002249697-2015-03672
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082567
• 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: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 5630-G-208
• Device Lot Number: MKL0KT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2011
• 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