MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CS INS SIZE 6 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-P-611
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that there was a large scratch on the insert.This was noticed during preparation for a procedure, prior to insertion.A new insert was used instead.
Event or Problem Description
It was reported that there was a large scratch on the insert.This was noticed during preparation for a procedure, prior to insertion.A new insert was used instead.
Additional Manufacturer Narrative
An event regarding an appearance issue (scratch) involving a triathlon insert was reported.The reported lines were visible however they represent markings typically associated with the manufacturing process.Method & results: device evaluation and results: the reported device with an opened blister, unit carton and ifu was returned for evaluation.The physical parts were visually examined by the hdp cell manufacturing engineer and the cell quality engineer, but no scratch was visible.The device was also visually inspected by hdp visual inspector as per qa3-022 and processed through cmm as per d03751 but was found not to have any markings/ridges other than those typically associated with the manufacturing process.Clinician review: no medical records were received for review with a clinical consultant device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.It was also noted that these parts also passed all visual and cmm inspections at the time of manufacturing.Complaint history review: there have been no other similar events for the reported lot.Conclusion: upon return, the physical parts were visually examined by the hdp cell manufacturing engineer and the cell quality engineer, but no scratch was visible.The device was also visually inspected by hdp visual inspector as per qa3-022 and processed through cmm as per d03751 but was found not to have any markings/ridges other than those typically associated with the manufacturing process.It was also noted that these parts also passed all visual and cmm inspections at the time of manufacturing.Therefore, it can be concluded that the part in question meets all the requirements and has been manufactured to the required specification.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON CS INS SIZE 6 11MM
• 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: 9537187
• Report Number: 0002249697-2020-00006
• Device Sequence Number: 16272553
• Product Code: MBH
• UDI-Device Identifier: 07613327042382
• UDI-Public: 07613327042382
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 02/26/2020

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: 04/30/2024
• Device Model Number: 5531-P-611
• Device Catalogue Number: 5531P611
• Device Lot Number: LJD714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 01/01/2020
• Supplement Report FDA Received Date: 02/26/2020
• 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