MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL STEM-STD NECK-SIZE 7 IMPLANT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	186003-07
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.  a supplemental report will be submitted when additional information becomes available.
Event or Problem Description
It was reported that the patient's right hip was revised.The patient fell and fractured her femur and humerus (surgeon reported poor bone quality as a contributing factor).A mako stem and ceramic head were revised to a restoration modular stem construct and another femoral head.Rep reported that he can provide pictures and that otherwise, no further information will be released by the hospital or surgeon.
Event or Problem Description
It was reported that the patient's right hip was revised.The patient fell and fractured her femur and humerus (surgeon reported poor bone quality as a contributing factor).A mako stem and ceramic head were revised to a restoration modular stem construct and another femoral head.Rep reported that he can provide pictures and that otherwise, no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving a mako stem was reported.The event was confirmed via clinician review of provided medical records.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs shows an explanted stem and ceramic head.The devices appear unremarkable.Minor damage in the form of scratches consistent with contact with explantation tooling is observed.The devices are covered in blood and tissue.-clinician review: a review of the provided medical information by a clinical consultant indicated: "the patient underwent a total hip arthroplasty which required revision in 2021 because of a periprosthetic fracture sustained in a fall.I can confirm that the event occurred since i was able to review the photograph of an x-ray showing a periprosthetic fracture.Regarding the possible root cause of this event, in my opinion it is directly a result of the fall.".-product history review: could not be performed as the provided device lot details were invalid.-complaint history review: could not be performed as the provided device lot details were invalid.Conclusions: it was reported that the patient fell and sustained a periprosthetic fracture of the reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs shows an explanted stem and ceramic head.The devices appear unremarkable.Minor damage in the form of scratches consistent with contact with explantation tooling is observed.The devices are covered in blood and tissue.A review of the provided medical information by a clinical consultant indicated: "the patient underwent a total hip arthroplasty which required revision in 2021 because of a periprosthetic fracture sustained in a fall.I can confirm that the event occurred since i was able to review the photograph of an x-ray showing a periprosthetic fracture.Regarding the possible root cause of this event, in my opinion it is directly a result of the fall." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: FEMORAL STEM-STD NECK-SIZE 7 IMPLANT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 12432269
• Report Number: 3005985723-2021-00156
• Device Sequence Number: 3536524
• Product Code: JDI
• UDI-Device Identifier: 00848486008079
• UDI-Public: 00848486008079
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: D231264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2022

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 Model Number: 186003-07
• Device Catalogue Number: 186003-07
• Device Lot Number: 100043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female