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	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Joint Dislocation (2374)
Date of Event	08/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding crack/fracture and disassociation of the poly portion involving a triathlon metal backed patella was reported.The event was confirmed based on the photographs provided.The reported device was not returned however photographs were provided for review.The photographs provided are poor quality.One of the photographs was captured intra-operatively, whereby what appears to be the poly part of the patellar component is visible.The other photograph the poly portion of the patellar component appears fractured and is disassociated from the metal back of the component.-clinician review: no medical records were received for review with a clinical consultant.All devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.The reported event regarding crack/fracture and disassociation of the poly portion is confirmed based on the photographs provided.The exact cause of the event could not be determined because insufficient information was provided.Additional information including device evaluation, operative reports, progress notes and x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
It was reported that the patient's knee was revised after patient complaint of pain and clicking.Intra- operatively, the poly part of the patellar component was found to have a portion broken off and all of the poly disassociate d from the metal part of the patellar component.The 2x11 cr insert was also revised after wear was noted.The patient was revised to an all poly patellar component and a new insert of the same catalog number.Rep provided an intra-op picture and explant pictures and confirmed that no further information will be released by the hospital or surgeon.

• 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: 9075124
• Report Number: 0002249697-2019-03216
• Device Sequence Number: 2529700
• Product Code: MBH
• UDI-Device Identifier: 07613327049909
• UDI-Public: 07613327049909
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2019

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: 06/30/2015
• Device Catalogue Number: 5554L350
• Device Lot Number: STYJF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 09/17/2019
• 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: 69 YR