MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM CEM FXD BPLT #5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5520B500

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2017

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicates the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that during setup of a primary tka procedure for patient's left knee, an implant was opened.Outer box was opened by the circulator and implant appeared to have some sort of defect while it was in the inner packaging.Rep reported it appeared to have been dented.Upon removal of the inner packaging, it became apparent that there was powdery residue on the implant.There were two places on the keel edge and one place on the edge of the rim of the baseplate that had powder.Surgeon refused to use the implant due to sterility concerns.In the time it took to unwrap the other devices, a new implant was procured.Rep reported as a result there was no delay to the start of the procedure.The part and packaging are available for return to stryker.Rep reported procedure was completed successfully with no adverse effects to the patient.

Manufacturer Narrative

An event regarding residue or foreign matter involving a triathlon baseplate was reported.The event was not confirmed.One baseplate without packaging was returned for evaluation.The device was returned in a plastic bag.There is evidence of scuffing on the plastic bag.The reported powder was not visible on the returned device.The device itself appears unremarkable.Medical records received and evaluation: not performed as no medical records were provided.Indicated all devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events reported for the lot referenced.The baseplate was returned in a plastic bag.When the device was removed from the plastic bag there was no "powdery residue" as reported on the baseplate.Movement within the plastic bag may have removed the debris from the implant as there was scuffing on the plastic bag.No photographs of the device were provided as it appeared in the operating room with the foreign matter on it.The exact cause of the event could not be determined because insufficient information was provided.Further information such as all packaging return is needed to complete the investigation for determining a root cause.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

It was reported that during setup of a primary tka procedure for patient's left knee, an implant was opened.Outer box was opened by the circulator and implant appeared to have some sort of defect while it was in the inner packaging.Rep reported it appeared to have been dented.Upon removal of the inner packaging, it became apparent that there was powdery residue on the implant.There were two places on the keel edge and one place on the edge of the rim of the baseplate that had powder.Surgeon refused to use the implant due to sterility concerns.In the time it took to unwrap the other devices, a new implant was procured.Rep reported as a result there was no delay to the start of the procedure.The part and packaging are available for return to stryker.Rep reported procedure was completed successfully with no adverse effects to the patient.

• Brand Name: TRIATHLON PRIM CEM FXD BPLT #5
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6846390
• MDR Text Key: 85044387
• Report Number: 0002249697-2017-02683
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327041057
• UDI-Public: 07613327041057
• 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: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2022
• Device Catalogue Number: 5520B500
• Device Lot Number: BP37E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2017
• 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: 57 YR
• Patient Weight: 113