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

Catalog Number	5554L350
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
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
It was reported that the patient's left knee was revised due to anterior pain.An a35 beaded patella and 7x9 cr insert were revised to an a35 x3 patella and 7x9 cr insert.Rep provided primary operative and webops reports, x-rays, and vitals and reported that additional x-rays, medical records, and further information are not available due to hospital policy.Update event per review of the provided picture by the consulting clinician: "provided picture of the explanted patella confirms wear.".
Additional Manufacturer Narrative
An event regarding anterior pain involving a triathlon patella was reported.Wear of the patella component was confirmed by visual inspection of the provided photograph.Method & results: product evaluation and results: the reported device was not returned however one photographs was provided for review.The photograph provided is of a recently explanted patella.Blood is visible on the patella.Wear is also visible on the bearing surface of the patella.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: provided picture of the explanted patella confirms wear.Need revision operative reports, office/clinical notes, histopathology reports, serial x-rays and examination of the explanted components.Product history review: indicated all devices were manufactured and accepted into final stock on with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: an event regarding anterior pain involving a triathlon patella was reported.Wear of the patella component was confirmed by visual inspection of the provided photograph.A review of the provided medical records by a clinical consultant stated the following comment: provided picture of the explanted patella confirms wear.The exact cause of the event could not be determined because insufficient information was provided.Further information such as revision operative reports, office/clinical notes, histopathology reports, serial x-rays and examination of the explanted components are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's left knee was revised due to anterior pain.An a35 beaded patella and 7x9 cr insert were revised to an a35 x3 patella and 7x9 cr insert.Rep provided primary operative and webops reports, x-rays, and vitals and reported that additional x-rays, medical records, and further information are not available due to hospital policy.Update event per review of the provided picture by the consulting clinician: "provided picture of the explanted patella confirms wear.".

• Brand Name: TRIATHLON MB PATELLA PA A35
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8232992
• Report Number: 0002249697-2019-00140
• Device Sequence Number: 11234506
• 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: 2013
• 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): 03/07/2019

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: 08/31/2017
• Device Catalogue Number: 5554L350
• Device Lot Number: S9E6M1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 03/07/2019
• 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: 61 YR
• Patient Weight: 102