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

Model Number	5552-L-381
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	01/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The sales rep reported a left knee surgery.The product did not fixate well and was unable to be retained.Sales rep indicated that the proper drill was used and device checked.Surgeon cemented tka rather than pressfit.
Additional Manufacturer Narrative
An event regarding a size/fit issue involving an tritanium patella was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection: the returned device was visually unremarkable dimensional inspection:the returned device was dimensionally inspected on return per igs-0030877 the device was found to be within the specified dimensional limits.-medical records received and evaluation: no information was received for review with the clinical consultant.-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 events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as operative reports, are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.
Event or Problem Description
The sales rep reported a left knee surgery.The product did not fixate well and was unable to be retained.Sales rep indicated that the proper drill was used & device checked.Surgeon cemented tka rather than pressfit.
Additional Manufacturer Narrative
The aer decision for this event was noted as malfunction however, the initial mdr mfr report # 0002249697-2017-00478 was submitted as a serious injury in error.This report is being filed to correct h1 type of reportable event to malfunction.
Event or Problem Description
The sales rep reported a left knee surgery.The product did not fixate well and was unable to be retained.Sales rep indicated that the proper drill was used & device checked.Surgeon cemented tka rather than pressfit.

• Brand Name: TRITANIUM PATELLA-ASYMMETRIC
• 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: 6307276
• Report Number: 0002249697-2017-00478
• Device Sequence Number: 19122551
• Product Code: MBH
• UDI-Device Identifier: 07613327013566
• UDI-Public: (01)07613327013566(11)161011(17)211031(10)AM2N
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 5552-L-381
• Device Catalogue Number: 5552-L-381
• Device Lot Number: AM2N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Initial Date Received by Manufacturer: 01/11/2017
• Supplement Date Received by Manufacturer: Not provided; 10/28/2020
• Initial Report FDA Received Date: 02/07/2017
• Supplement Report FDA Received Date: 04/05/2017; 10/29/2020
• 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: Other
• Patient Age: 65 YR
• Patient Weight: 95