MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN MAKO INSERT; HIP IMPLANT

Catalog Number UNK_OFL

Device Problem Naturally Worn (2988)

Patient Problems Injury (2348); Osteolysis (2377)

Event Date 08/07/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding tibial loosening involving a mako baseplate was reported.The event was confirmed through clinician review of the medical records provided.Osteolysis due to the presence of cement debris was also identified through clinician review.Method & results: product evaluation and results: not performed as no product was returned for evaluation.No photographs were provided for review.Clinician review: a review of the provided medical records by a clinical consultant indicated: bone cement remnants in and around the joint space after cementation of a mako partial knee device contributed to third-body wear effects with early osteolysis and consequent tibial loosening requiring revision.Because cementation is part of surgical technique under responsibility of the surgeon, principal failure mode is procedure-related.Product history review: not performed as no lot information was provided.Complaint history review: not performed as no lot information was provided.Conclusion: an event regarding revision due to loosening was reported.The medical review indicated that: bone cement remnants in and around the joint space after cementation of a mako partial knee device contributed to third-body wear effects with early osteolysis and consequent tibial loosening requiring revision.Because cementation is part of surgical technique under responsibility of the surgeon, principal failure mode is procedure-related.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Not returned to the manufacturer.

Event Description

Mako uni pka performed (b)(6) 2018.Revised to tka for tibial loosening (b)(6) 2018.Revised to triathlon tka.

• Brand Name: UNKNOWN MAKO INSERT
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7960623
• MDR Text Key: 123534667
• Report Number: 3005985723-2018-00582
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2018

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 Catalogue Number: UNK_OFL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2018
• Initial Date FDA Received: 10/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 88