MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 8 MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	180734-1-E
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Injury (2348)
Date of Event	02/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.
Event or Problem Description
As reported: "patient came in on (b)(6) 2020 to see dr.For limited motion in her left knee.She missed a couple of her therapy appointments prior.Limited motion of 5-90 degrees.Patient wanted a manipulation.Closed manipulation under anesthesia occurred on (b)(6) 2020.".
Additional Manufacturer Narrative
An event regarding rom involving a mako insert was reported.The event was confirmed via medical review.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: the review of these records confirmed the complaint of postoperative limited motion of her left knee and a manipulation under anesthesia at the 3 month postoperative mark.The poor range of motion may have been contributed to by patient related comorbid factors, the postoperative physical therapy protocols, and/or postoperative monitoring.No device related factors were contributory to this event.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical information by a clinical consultant indicated: the review of these records confirmed the complaint of postoperative limited motion of her left knee and a manipulation under anesthesia at the 3 month postoperative mark.The poor range of motion may have been contributed to by patient related comorbid factors, the postoperative physical therapy protocols, and/or postoperative monitoring.No device related factors were contributory to this event.No further investigation for this event is possible at this time as no devices and/ or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
As reported: "patient came in on (b)(6) 2020 to see dr.For limited motion in her left knee.She missed a couple of her therapy appointments prior.Limited motion of 5-90 degrees.Patient wanted a manipulation.Closed manipulation under anesthesia occurred on (b)(6) 2020.".
Event or Problem Description
As reported: "patient came in on (b)(6) 2020 to see dr.For limited motion in her left knee.She missed a couple of her therapy appointments prior.Limited motion of 5-90 degrees.Patient wanted a manipulation.Closed manipulation under anesthesia occurred on (b)(6) 2020.".
Additional Manufacturer Narrative
An event regarding rom involving a mako insert was reported.The event was confirmed via medical review.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: the review of these records confirmed the complaint of postoperative limited motion of her left knee and a manipulation under anesthesia at the 3 month postoperative mark.The poor range of motion may have been contributed to by patient related comorbid factors, the postoperative physical therapy protocols, and/or postoperative monitoring.No device related factors were contributory to this event.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical information by a clinical consultant indicated: the review of these records confirmed the complaint of postoperative limited motion of her left knee and a manipulation under anesthesia at the 3 month postoperative mark.The poor range of motion may have been contributed to by patient related comorbid factors, the postoperative physical therapy protocols, and/or postoperative monitoring.No device related factors were contributory to this event.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 8 MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9824814
• Report Number: 3005985723-2020-00149
• Device Sequence Number: 743240
• Product Code: MBH
• UDI-Device Identifier: 07613327385984
• UDI-Public: 07613327385984
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K150307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2021

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: 07/31/2024
• Device Model Number: 180734-1-E
• Device Catalogue Number: 180734-1
• Device Lot Number: DV7W2N
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 04/14/2020; 05/12/2021
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 05/07/2020; 06/07/2021
• 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: 55 YR
• Patient Weight: 97