MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR BASEPLATE #4 LM/RL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 5620-B-401

Device Problem Device Packaging Compromised (2916)

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

Event Date 12/02/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Our distributor reported that the package of the device was sealed with the plastic film outside the box, but it was not intact internally.Another device, same size was available, so no surgical delay.

Manufacturer Narrative

An event regarding delamination of inner (b)(6) involving a triathlon pkr baseplate #4 lm/rl was reported.The event was confirmed.Method and results: device evaluation: the returned device confirmed the event as the tyvek of the inner blister did delaminate.Clinician review: not performed as medical records were not received for review with a clinical consultant.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there have been no similar previous reported events for this lot id.Conclusions: visual inspection of the returned indicated a corner of the inner (b)(6) lid had delaminated.It is possible the corner of the lid stuck to the outer (b)(6) lid, causing it to delaminate when the outer lid was peeled back.The inner lid was observed to be stuck to the foam.The root cause was determined to be a known packaging issue.Packaging innovations is aware of this, and has issued a memo.If additional information is received, this investigation will be reopened and re-evaluated.

Event Description

Our distributor reported that the package of the device was sealed with the plastic film outside the box, but it was not intact internally.Another device, same size was available, so no surgical delay.

• Brand Name: TRIATHLON PKR BASEPLATE #4 LM/RL
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5313768
• MDR Text Key: 34739281
• Report Number: 0002249697-2015-04375
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K082567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 5620-B-401
• Device Lot Number: KUHTA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2014
• 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