MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5520-B-300

Device Problems Shipping Damage or Problem (1570); Device Packaging Compromised (2916)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 04/28/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported that as they opened up the triathlon femur packaging in [the hospital], the outside carton and shrink wrap were intact, but the white layer on top of the implant itself that is normally peeled back had detached from the plastic and the seal was breached.

Manufacturer Narrative

An event regarding packaging damage involving a triathlon baseplate was reported.The event was confirmed.Method & results: device evaluation and results: the unit carton with its shrink wrap opened on one side, the outer blister and the inner blister containing the device were returned for evaluation.There is severe compression and line indentations on the front of the unit carton.There is evidence of compression and line indentation along both sides of the unit carton.This evidence is an indication of excessive/inappropriate handling.The outer blister was returned with the tyvek lid fully removed from the blister pack.One of the outer blister flanges has been completely fractured off and is still adhered to the tyvek lid.This type of damage would be consistent with a shock load, e.G.The carton being dropped from a height and/or compression.There is evidence of a good seal on the remaining three sides of the outer blister.The inner blister was returned with the tyvek lid still attached.For the purpose of this investigation the tyvek lid was removed from the inner blister.There is evidence of a good seal on the inner blister.The returned device appears unremarkable.Medical records received and evaluation: not performed as the event relates to a packaging issue.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events reported for the lot referenced.Conclusions: based on the visual inspection of the returned packaging it appears that this component packaging was subjected to excessive/inappropriate handling whereby the carton may have been compressed and/or dropped from a height causing damage to the unit carton.No further investigation for this event is possible at this time.

Event Description

The customer reported that as they opened up the triathlon femur packaging in [the hospital], the outside carton and shrink wrap were intact, but the white layer on top of the implant itself that is normally peeled back had detached from the plastic and the seal was breached.

• Brand Name: TRIATHLON PRIM TIB BASEPLATE - CEMENTED
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6597509
• MDR Text Key: 76381436
• Report Number: 0002249697-2017-01713
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Public: (01)(11)161215(17)211215(10)BTR7T
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 5520-B-300
• Device Lot Number: BTR7T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2016
• 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