MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON MB PATELLA PA A38; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number	5554L381
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	12/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.Additional devices listed in this report: catalog: 5517f501, description: triathlon p/a cr beaded #5l, lot: s983f.Catalog: 5530-g-509, description triathlon cr x3 tibial insert, lot: mltv3n.Catalog: 5526b500, description: triathlon prim bead pa sze5 bp, lot: ebtcl.At this time, it cannot be determined which, if any of the reported devices may have caused or contributed to the patient's experience.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 the patient's left knee was revised due to pain in the anterior knee.An a38 beaded patella was revised to an a38 x3 patella.
Event or Problem Description
It was reported that the patient's left knee was revised due to pain in the anterior knee.An a38 beaded patella was revised to an a38 x3 patella.
Additional Manufacturer Narrative
An event regarding pain, wear and misalignment involving a triathlon patella was reported.Wear (through visual inspection) and misalignment (through visual inspection and a clinicians review of the provided explant image and x-ray) were confirmed.Pain was not confirmed.Method & results: device evaluation and results: visual inspection: the reported device was not returned however a photograph was provided for review.The photograph shows a recently explanted patella with the presence of biological matter.From the photograph provided there is evidence of wear of the device.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation :a review of the provided medical information by a clinical consultant indicated: rejected for medical review by dr.Jaffe on (b)(6) 2019: provided x-ray confirms a tilted patella.Provided picture of the explanted patella confirms wear.Need primary and revision operative reports, office/clinical notes, histopathology reports, 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 operative and revision operative reports, office/clinical notes, histopathology reports, 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 A38
• Common Device Name: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8232708
• Report Number: 0002249697-2019-00137
• Device Sequence Number: 10811830
• Product Code: MBH
• UDI-Device Identifier: 07613327049916
• UDI-Public: 07613327049916
• 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: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2019

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: 09/30/2017
• Device Catalogue Number: 5554L381
• Device Lot Number: S938P1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 01/09/2019
• Supplement Report FDA Received Date: 03/15/2019
• 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: 87