MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A PS BEADED #6R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5516F602

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2018

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that surgeon was performing a primary knee surgery and upon opening the implant, the inner box/blister was broken and surgeon thought sterility may be compromised as a result and opted not to use this device but another was on hand and readily available so surgeon used another device of same size/cat and completed the surgery without any delay.

Manufacturer Narrative

An event regarding pack damage involving a triathlon femoral component was reported.The event was confirmed by visual inspection of the returned product.One unit carton without its shrink wrap was returned for evaluation.Compression and indentation lines are visible on the opening end, corners and on the underside of the unit carton.The outer blister was returned with the tyvek lid attached on two sides.A patient label sticker is attached to the tyvek lid.For the purpose of this investigation the tyvek lid was removed from the outer blister.One side flange of the outer blister is broken away and remains attached to the tyvek lid.One side flange is also cracked but remains attached to the outer blister.There is evidence of a good seal on the remaining sides of the outer blister.The inner blister was returned unopened inside the outer blister.For the purpose of this investigation the tyvek lid was removed from the inner blister.There is evidence of a good seal between the tyvek lid and the inner blister.The returned device appears unremarkable.No medical records were received for review with a clinical consultant.Indicated all devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.Review of the returned product indicated: one unit carton without its shrink wrap was returned for evaluation.Compression and indentation lines are visible on the opening end, corners and on the underside of the unit carton.The outer blister was returned with the tyvek lid attached on two sides.A patient label sticker is attached to the tyvek lid.For the purpose of this investigation the tyvek lid was removed from the outer blister.One side flange of the outer blister is broken away and remains attached to the tyvek lid.One side flange is also cracked but remains attached to the outer blister.There is evidence of a good seal on the remaining sides of the outer blister.The inner blister was returned unopened inside the outer blister.For the purpose of this investigation the tyvek lid was removed from the inner blister.There is evidence of a good seal between the tyvek lid and the inner blister.The returned device appears unremarkable.This damage is consistent with inappropriate/excessive handling.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that surgeon was performing a primary knee surgery and upon opening the implant, the inner box/blister was broken and surgeon thought sterility may be compromised as a result and opted not to use this device but another was on hand and readily available so surgeon used another device of same size/cat and completed the surgery without any delay.

• Brand Name: TRIATHLON P/A PS BEADED #6R
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7837155
• MDR Text Key: 118897630
• Report Number: 0002249697-2018-02737
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327041583
• UDI-Public: 07613327041583
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

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 Expiration Date: 01/31/2023
• Device Catalogue Number: 5516F602
• Device Lot Number: B4A3T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Initial Date Manufacturer Received: 08/06/2018
• Initial Date FDA Received: 08/31/2018
• Supplement Dates Manufacturer Received: 09/07/2018
• Supplement Dates FDA Received: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR