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

Catalog Number 5554L350

Device Problems Material Deformation (2976); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 07/23/2018

Event Type  Injury  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 117613918
• Report Number: 0002249697-2018-02577
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327049909
• UDI-Public: 07613327049909
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Catalogue Number: 5554L350
• Device Lot Number: SK4RK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 08/20/2018
• Supplement Dates Manufacturer Received: 09/12/2018
• Supplement Dates FDA Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 90