MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED; IMPLANT

Catalog Number 5515-F-301

Device Problems Device Damaged Prior to Use (2284); Tear, Rip or Hole in Device Packaging (2385); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 06/17/2015

Event Type  malfunction  

Event Description

It was reported that, when a nurse opened the product box, she noticed the broken outer blister pack.The inner pack had no damage therefore the component was used.

Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

Manufacturer Narrative

An event regarding packaging damage involving a triathlon femoral component was reported.The event was confirmed.Method & results: device evaluation and results: based on the visual inspection of the returned packaging it appears that this component packaging was subjected to excessive/inappropriate handling during transportation/storage whereby the carton had been compressed.Medical records received and evaluation: not performed as the event is related to a packaging issue and no adverse consequences to the patient were reported.Device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.Complaint history review: there have been no other events for the lot referenced.Conclusions: the investigation concluded that the packaging damage was most likely caused by excessive/incorrect handling prior to the opening packaging.No further investigation for this event is required at this time.

Event Description

It was reported that, when a nurse opened the product box, she noticed the broken outer blister pack.The inner pack had no damage therefore the component was used.

• Brand Name: TRIATHLON PS FEM COMPONENT, CEMENTED
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK (MDR); raheen business park; limerick NA
• Manufacturer Contact: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4906196
• MDR Text Key: 21802360
• Report Number: 0002249697-2015-02293
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141056
• 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: 06/17/2015

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: 06/30/2019
• Device Catalogue Number: 5515-F-301
• Device Lot Number: EJ9ET
• Other Device ID Number: STERILE LOT: R6126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/17/2015
• Initial Date FDA Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/28/2014
• 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