MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR BASEPLATE #2 RM/LL; IMPLANT

Catalog Number 5620-B-202

Device Problems Break (1069); Difficult to Insert (1316); Material Distortion (2977); Material Integrity Problem (2978)

Patient Problems Injury (2348); No Information (3190)

Event Date 11/10/2014

Event Type  Injury  

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

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

Manufacturer Narrative

An event regarding difficulty seating a triathlon pkr insert into a baseplate was reported.The event was confirmed.Method & results: device evaluation and results: a visual inspection showed the device to be unremarkable.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 the observed damage on the anterior portion of the locking feature was preventing the device from being fully seated.This damage likely occurred as a result of attempting to implant the insert while it was not fully aligned with the baseplate.

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 BASEPLATE #2 RM/LL
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4303399
• MDR Text Key: 5194072
• Report Number: 0002249697-2014-04522
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 5620-B-202
• Device Lot Number: JPAUA
• Other Device ID Number: STERILE LOT# MSHNJ28A3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2014
• 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