MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON ASYM PATELLA A32X10; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5551-L-320
Medical Device Problem Codes	Off-Label Use (1494); Osseointegration Problem (3003); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	08/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Device not returned.
Event or Problem Description
Gave surgeon the wrong implant.Cemented patella was put in, in an uncemented nature.A second surgery is required to remove patella and place a correct patella.
Additional Manufacturer Narrative
Reported event: an event regarding incorrect selection (surgeon was given wrong implant.Cemented patella was put in, in an uncemented nature) and loosening was reported.Conclusion: the event indicates that the surgeon planned to use an uncemented patella, but used a cemented patella in an uncemented nature by mistake.It took a week to discover, patella implant became loose.Packaging insert qin 4376 rev ab indicates "components labeled for ¿cemented use only¿ are to be implanted only with bone cement".Based on the provided information it has been determined that this event is associated with an off-label application.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
Gave surgeon the wrong implant.Cemented patella was put in, in an uncemented nature.A second surgery is required to remove patella and place a correct patella.

• Brand Name: TRIATHLON ASYM PATELLA A32X10
• 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: 10499243
• Report Number: 0002249697-2020-01800
• Device Sequence Number: 19573590
• Product Code: MBH
• UDI-Device Identifier: 07613327049855
• UDI-Public: 07613327049855
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

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: 03/31/2025
• Device Model Number: 5551-L-320
• Device Catalogue Number: 5551L320
• Device Lot Number: LJT691
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 09/07/2020
• Supplement Report FDA Received Date: 11/06/2020
• 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: 71 YR