MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #5 PS INSERT 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5532P511
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/26/2018
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 events for the reported lot.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that upon opening the product packaging, it appeared the insert was contaminated.
Event or Problem Description
It was reported that upon opening the product packaging, it appeared the insert was contaminated.
Additional Manufacturer Narrative
Conclusion: a batch and process quality review was completed for the complaint lot.There was no issue recorded in the batch device history record.No previous complaints were received for the batch.The material was identified by ftir as potentially being adhesive tape.Candidate samples from production areas were submitted for analysis.No definitive match was made.This complaint could not be confirmed as being manufacturing related, however a potential non-conformance record nc (b)(4) was initiated to review all processing areas to identify the potential risk of this type of contaminant.Where adhesive tape was present in the processing areas, it was removed.The adhesive tape in these locations were submitted as samples that were analysed and not found to match the complaint.There is no direct product contact with these surfaces, this is a precautionary measure.

• Brand Name: TRIATHLON #5 PS INSERT 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: 7363268
• Report Number: 0002249697-2018-00850
• Device Sequence Number: 1233666
• Product Code: MBH
• UDI-Device Identifier: 07613327042801
• UDI-Public: 07613327042801
• 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: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2018

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: 12/31/2022
• Device Catalogue Number: 5532P511
• Device Lot Number: LHE897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 07/10/2018
• 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