MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON ASYMMETRIC X3 PATELLA; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5551-G-320
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate that 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 or Problem Description
Upon opening the patella implant, a hair was found on the device.Rep was present in the operating room at the time of discovery.Due to sterility concerns, the device was not used and removed immediately from the field.A replacement device was immediately available.
Additional Manufacturer Narrative
An event regarding a hair on the device involving a trident patella was reported.The event was confirmed.The implant, inner blister, inner tyvek sheet, box and product label was returned.The foreign matter was taped to the product label.Medical records received and evaluation: not performed as it was reported that there were no adverse consequences nor medical intervention.Device history review: there were no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.The investigation concluded the returned packaging to be nonconforming.Visual inspection of the returned product confirmed a small piece of hair was on the device.Nc pr was raised to investigate the confirmed issue.It was determined that the scope can be restricted to this one piece based on the 100% verification of product after the inner and outer blister sealing operation and the passing in-process testing results.
Event or Problem Description
Upon opening the patella implant, a hair was found on the device.Rep was present in the o.R.At the time of discovery.Due to sterility concerns, the device was not used and removed immediately from the field.A replacement device was immediately available.

• Brand Name: TRIATHLON ASYMMETRIC X3 PATELLA
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7225666
• Report Number: 0002249697-2018-00275
• Device Sequence Number: 19086742
• Product Code: MBH
• UDI-Device Identifier: 07613327014815
• UDI-Public: 07613327014815
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 5551-G-320
• Device Lot Number: HXKD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Initial Date Received by Manufacturer: 01/04/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 01/29/2018
• Supplement Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR