MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #3 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5510F301

Device Problems Device Damaged Prior to Use (2284); Tear, Rip or Hole in Device Packaging (2385); Device Packaging Compromised (2916); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 12/13/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The nurse in the room opened the outside box to open the implant and the inside package was damaged (cracked).

Manufacturer Narrative

An event regarding packaging damage involving a triathlon femoral component was reported.The event was confirmed.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 carton and outer blister.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 similar events for the lot referenced.The investigation concluded that the packaging damage was most likely caused by excessive/incorrect handling prior to the opening packaging whereby the carton may have been compressed and/or dropped from a height causing the damage to the carton making it difficult to remove the device.No further investigation for this event is required at this time.

Event Description

The nurse in the room opened the outside box to open the implant and the inside package was damaged (cracked).

• Brand Name: TRIATHLON CR FEM COMP #3 L-CEM
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6239321
• MDR Text Key: 64728076
• Report Number: 0002249697-2017-00160
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327040258
• UDI-Public: (01)07613327040258(11)160826(17)210831(10)BEH2L
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2017

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: 08/31/2021
• Device Catalogue Number: 5510F301
• Device Lot Number: BEH2L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 01/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2016
• 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
• Patient Age: 59 YR
• Patient Weight: 62