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

Catalog Number 5510F701

Device Problems Contamination (1120); Device Damaged Prior to Use (2284); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 12/16/2015

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

It was reported that when the circulating nurse peeled the sterile seal off of the packaging a thin piece of plastic sheared off of the plastic package and stuck to the paper seal.The packaging was deemed contaminated and femur was not implanted.

Manufacturer Narrative

An event regarding packaging damage involving a triathlon femoral component was reported.The event was confirmed.Method and results: device evaluation and results: the unit carton and shrik wrap were returned for evaluation.The unit carton illustrated signs of compression damage.There are significant commpression lines along the opening side of the carton and on some of the corners of the box.The (b)(6) lid on the outer blister was removed.The flange of the outer blister is cracked and broken on one side.The broken side of the flange remains attached to the (b)(6) lid.There is evidence of a good seal on the outer blister.The inner blister was returned unopened.The inner blister was opened as part of this investigation, there is evidence of a good seal between the inner blister and the (b)(6) lid.The returned device looked unremarkable.It appears that this component packaging was subjected to excessive handling whereby the unit carton was compressed to the extent that the outer blister flange cracked under the compressive force it was subjected to.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 caused by excessive/incorrect handling.No further investigation for this event is required at this time.

Event Description

It was reported that when the circulating nurse peeled the sterile seal off of the packaging a thin piece of plastic sheared off of the plastic package and stuck to the paper seal.The packaging was deemed contaminated and femur was not implanted.

• Brand Name: TRIATHLON CR FEM COMP #7 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: 5364969
• MDR Text Key: 36273659
• Report Number: 0002249697-2016-00041
• 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: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2015

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: 08/31/2020
• Device Catalogue Number: 5510F701
• Device Lot Number: AKL8F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2015
• Initial Date FDA Received: 01/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2015
• 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