MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #7 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5510F702

Device Problems Delivered as Unsterile Product (1421); Shipping Damage or Problem (1570); Device Packaging Compromised (2916); Packaging Problem (3007); Torn Material (3024)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2017

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

It was reported that the outer plastic packaging tore when opening the paper top of the femoral implant.The sterility of the implant was never in question prior to opening the unsterile encasing and presenting the inside sterile implant encasing to the scrub nurse.When the circulating nurse peeled back the lid of the unsterile plastic casing to present to the scrub nurse, the plastic tore and stuck to the paper covering.Because of this, the outer unsterile packaging was then in contact with the inside sterile packaging.This then renders the implant "questionable" in regards to sterility and the decision was made to not accept the implant.

Manufacturer Narrative

Product returned.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 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.-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.Conclusions: 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.No further investigation for this event is required at this time.

Event Description

It was reported that the outer plastic packaging tore when opening the paper top of the femoral implant.The sterility of the implant was never in question prior to opening the unsterile encasing and presenting the inside sterile implant encasing to the scrub nurse.When the circulating nurse peeled back the lid of the unsterile plastic casing to present to the scrub nurse, the plastic tore and stuck to the paper covering.Because of this, the outer unsterile packaging was then in contact with the inside sterile packaging.This then renders the implant "questionable" in regards to sterility and the decision was made to not accept the implant.

Manufacturer Narrative

Corrected awareness date to 04/21/2017.

Event Description

It was reported that the outer plastic packaging tore when opening the paper top of the femoral implant.The sterility of the implant was never in question prior to opening the unsterile encasing and presenting the inside sterile implant encasing to the scrub nurse.When the circulating nurse peeled back the lid of the unsterile plastic casing to present to the scrub nurse, the plastic tore and stuck to the paper covering.Because of this, the outer unsterile packaging was then in contact with the inside sterile packaging.This then renders the implant "questionable" in regards to sterility and the decision was made to not accept the implant.

• Brand Name: TRIATHLON CR FEM COMP #7 R-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: 6382609
• MDR Text Key: 69360372
• Report Number: 0002249697-2017-00799
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 5510F702
• Device Lot Number: EHHKY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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