MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK FEMORAL-LM-RL-SZ 4; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P

Catalog Number	180504
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
Event or Problem Description
Tech dropped actual femoral implant on the ground.Upon inspection i noticed that actual implant lot code does not match outer box or implant stickers.Sticker says 559782-m.
Additional Manufacturer Narrative
An event regarding label content discrepancy involving a mako femoral component was reported.The event was confirmed by photographs.Method & results: product evaluation and results: the device was not returned however, an image of the packaging and implant was provided.The implant noted the catalog number to be 180504 and lot number 2938001.The product label on the implant sheet noted the catalog number to be 180504 and the lot number to be 559782-m.Clinician review: not performed as medical records were not provided for review.Product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the investigation concluded that the lot number on the label and implant did not match as this is part of the manufacturing process.The supplier certifications note that multiple base lots were manufactured and sterilized under the mako lot which is the "559782-m" lot number, which follows the mako procedure qip 0029, inspection of metallic implant components, section 9.3.13.2.2.The lot number noted on the part is traceable through the router which notes that this lot was indeed manufactured.No further investigation for this event is possible at this time.
Event or Problem Description
Tech dropped actual femoral implant on the ground.Upon inspection i noticed that actual implant lot code does not match outer box or implant stickers.Sticker says 559782-m.

• Brand Name: MCK FEMORAL-LM-RL-SZ 4
• Common Device Name: KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8249469
• Report Number: 3005985723-2019-00059
• Device Sequence Number: 1439241
• Product Code: NPJ
• UDI-Device Identifier: 00848486000561
• UDI-Public: 00848486000561
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2019

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: 08/30/2023
• Device Catalogue Number: 180504
• Device Lot Number: 2938001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 03/15/2019
• 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: Other