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

Catalog Number 5620-B-202

Device Problems Device Inoperable (1663); Malposition of Device (2616)

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

Event Date 05/06/2014

Event Type  malfunction  

Event Description

The product manager reported on behalf of the customer that during a pkr (triathlon uni knee) procedure, the surgeon wanted to place the tibial implant with cement on it into the patient.The product manager reported that all the required steps for the procedure had been followed.Minimal resection levels leave a gap of 15 mm.The tibial implant is also 15 mm in total height (plate and pegs).It was reported that the surgeon was not able to place the implant into the patient due to lack of space and after 7 tries he removed the implant (which was never fully seated) and the cement of the implant and discussed an alternative way to create space and place the implant.The product manager reported that on the second try the surgeon succeeded; the patient laxity allowed for a re-placing of the homann handles, so the tibia could be pushed forward.The product manager reported that the procedure was completed by removing the cement from the implant, mixing new cement, replacing the homaan handles and using the same cleaned up implant.The project manager reported that there was a delay in surgery of 20 minutes.

Manufacturer Narrative

It was noted that the device is not available for evaluation because it remains implanted in the patient.Additional information has been requested and if received, will be provided in the supplemental report.

Manufacturer Narrative

The event could not be confirmed nor the root cause of the reported event determined due to the minimal information received.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.

Event Description

The sales rep reported that the surgeon followed the operation technique and the order of implantation of the different components.He also used the navigation for correct balancing and positioning of the implants.According to the navigation this was the optimal situation for a good balanced knee.The surgeon allegedly could not saw more or make a smaller release as this would have resulted in an unbalanced knee.

Manufacturer Narrative

An event regarding a seating issue involving a triathlon baseplate was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as no items were returned, the baseplate component was implanted.Medical records received and evaluation: not performed as no medical records were provided.Device history review: a review of the device history records could not be performed because the device associated with this event was not returned nor was it properly identified.Complaint history review: a complaint history review for similar events for the manufacturing lot could not be performed because the device associated with this event was not returned nor was it properly identified.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device return and operative notes are needed to complete the investigation for determining a root cause.No further investigation for this event is possible at this time.If devices or additional information become available, this investigation will be reopened.

Event Description

The product manager reported on behalf of the customer that during a pkr (triathlon uni knee) procedure, the surgeon wanted to place the tibial implant with cement on it into the patient.The product manager reported that all the required steps for the procedure had been followed.Minimal resection levels leave a gap of 15mm.The tibial implant is also 15mm in total height (plate and pegs).It was reported that the surgeon was not able to place the implant into the patient due to lack of space and after 7 tries he removed the implant (which was never fully seated) and the cement of the implant and discussed an alternative way to create space and place the implant.The product manager reported that on the second try the surgeon succeeded; the patient laxity allowed for a re-placing of the (b)(4) handles, so the tibia could be pushed forward.The product manager reported that the procedure was completed by removing the cement from the implant, mixing new cement, replacing the (b)(4) handles and using the same cleaned up implant.The project manager reported that there was a delay in surgery of 20 minutes.

• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3808106
• MDR Text Key: 4371461
• Report Number: 0002249697-2014-01854
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K082567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2014

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 Catalogue Number: 5620-B-202
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2015
• Initial Date FDA Received: 05/13/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/17/2015; 07/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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