MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON MB PATELLA PA A35; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5554L350
Medical Device Problem Codes	Material Deformation (2976); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	07/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported relevant discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that patient's left knee was revised.As reported by rep: "pain and clicking in anterior knee".An a35 patella and 5/9 cr insert were revised to an a38 x3 patella and 5/11 cr insert.
Event or Problem Description
It was reported that patient's left knee was revised.As reported by rep: "pain and clicking in anterior knee".An a35 patella and 5/9 cr insert were revised to an a38 x3 patella and 5/11 cr insert.
Additional Manufacturer Narrative
An event regarding wear, pain and audible noise involving a triathalon patella was reported.The wear was confirmed however, the pain and audible noise was not confirmed.Method & results: -device evaluation and results: material analysis, functional and dimensional inspections could not be performed as the device was not returned.Visual inspection: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted patella along with the presence of biological matter.From the photographs provided there is evidence of wear of the device.-medical records received and evaluation: rejected for medical review: "need revision operative notes, patient clinical notes, histopathology, serial x-rays, and examination of the explanted components." -device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including 'revision operative notes, patient clinical notes, histopathology, serial x-rays, and examination of the explanted components' are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: TRIATHLON MB PATELLA PA A35
• 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: 7797876
• Report Number: 0002249697-2018-02577
• Device Sequence Number: 2061587
• Product Code: MBH
• UDI-Device Identifier: 07613327049909
• UDI-Public: 07613327049909
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2014
• Device Catalogue Number: 5554L350
• Device Lot Number: SK4RK
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 10/10/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 90