MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN HIP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	180704-1
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Joint Dislocation (2374)
Date of Event	06/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Device not available.
Event or Problem Description
The subjects was performed the right knee artificial unicondylar joint replacement procedure on (b)(6) 2018.The subjects recovered very well and discharged from hospital on (b)(6) 2018.The subjects feel pain on his left hip joint.After confirmed by doctor, the subjects left hip joint was dislocated.The patients' left hip joint feel pain.The doctor performed the surgical reduction of dislocation of left hip joint to patient.
Additional Manufacturer Narrative
Correction: lot and catalog numbers removed.An event regarding  dislocation involving an unknown hip was reported. the event was confirmed through review of the provided x-ray by a clinical consultant.    method & results:  device evaluation and results: not performed as product was not returned.  clinician review: a review of the provided medical records by a clinical consultant stated the following comment: provided x-ray confirms dislocation, need additional translated information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays.Device history review: could not be performed as lot code information was not provided.  complaint history review: could not be performed as lot code information was not provided.  conclusion:  the exact cause of the event could not be determined because insufficient information was provided.  additional information including device details, additional translated information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
The subjects was performed the right knee artificial unicondylar joint replacement procedure on (b)(6) 2018.The subjects recovered very well and discharged from hospital on (b)(6) 2018.The subjects feel pain on his left hip joint.After confirmed by doctor, the subjects left hip joint was dislocated.The patients' left hip joint feel pain.The doctor performed the surgical reduction of dislocation of left hip joint to patient.

• Brand Name: UNKNOWN HIP
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8836505
• Report Number: 3005985723-2019-00536
• Device Sequence Number: 448655
• Product Code: LPH
• UDI-Device Identifier: 00848486000882
• UDI-Public: 00848486000882
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

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: 06/30/2022
• Device Catalogue Number: 180704-1
• Device Lot Number: 12020417-1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 10/28/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 55