MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #5 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5510F501

Device Problems Material Discolored (1170); Device Markings/Labelling Problem (2911)

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

Event Date 11/18/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

There was a mark/spot on the lateral posterior condyle of a left femur implant, possibly a water mark.Surgeon found prior to implantation and requested a new implant.

Manufacturer Narrative

An event regarding marks/stains involving a triathlon femoral component was reported.The event was confirmed.Method and results: device evaluation and results: visual inspection was completed on the device returned in the opened packaging and confirmed that femoral component had marks/stains on its internal fixation and external bearing surfaces.However, due to an unintended decontamination of the returned device, both the triathlon manufacturing cell and the packaging cell indicated that because of the unintended decontamination, it cannot be determined that this issue occurred in the (b)(4) manufacturing facility.Medical records received and evaluation: not performed as no medical information was provided.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: complaint history review confirmed that there have been no other similar events for the reported lot.Conclusion: a review of both the triathlon manufacturing cell and the packaging cell indicated that because of the unintended decontamination of the returned device, it cannot be determined that the observed marks/stains originated in the (b)(4) manufacturing facility.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

There was a mark/spot on the lateral posterior condyle of a left femur implant, possibly a water mark.Surgeon found prior to implantation and requested a new implant.

• Brand Name: TRIATHLON CR FEM COMP #5 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: 5293582
• MDR Text Key: 34024679
• Report Number: 0002249697-2015-04249
• Device Sequence Number: 1
• Product Code: MBH
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 5510F501
• Device Lot Number: EJTMM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2014
• 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