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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OPTIMIZED ORTHO PTY LTD CORIN OPTIMIZED POSITIONING SYSTEM; HIP PROSTHESIS
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OPTIMIZED ORTHO PTY LTD CORIN OPTIMIZED POSITIONING SYSTEM; HIP PROSTHESIS Back to Search Results
Model Number 1248_0500
Device Problems Manufacturing, Packaging or Shipping Problem (2975); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Unspecified Infection (1930); Discomfort (2330); Patient Problem/Medical Problem (2688)
Event Date 01/28/2020
Event Type  Injury  
Manufacturer Narrative
Patient underwent primary procedure for tha on (b)(6) 2018.Patient has recently complained of discomfort.X rays showed evidence that the liner was disengaging with the cup.Therefore, patient underwent revision procedure on the (b)(6) 2020.During revision procedure, the surgeon representative found that the patient experienced infection few months after primary procedure and was already revised on (b)(6) 2018.Summary: primary tha procedure: (b)(6) 2018.Revision procedure for infection: (b)(6) 2018.Revision procedure for liner loosening : (b)(6) 2020.During primary procedure , ops technology (ops and ops femoral ) were employed as assistive technology.This report is filed with the fda due to an event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.
 
Event Description
Patient underwent primary procedure for tha on (b)(6) 2018.Patient has recently complained of discomfort.X rays showed evidence that the liner was disengaging with the cup.Therefore, patient underwent revision procedure on the (b)(6) 2020.During revision procedure, the surgeon representative found that the patient experienced infection few months after primary procedure and was already revised on (b)(6) 2018.Summary: primary tha procedure: (b)(6) 2018.Revision procedure for infection: (b)(6) 2018.Revision procedure for liner loosening : (b)(6) 2020.During primary procedure , ops technology (ops and ops femoral ) were employed as assistive technology.This event occurred in (b)(6).
 
Manufacturer Narrative
Method: no complaint devices were returned to optimized ortho by the customer.Thus, the device history files were investigated which included reviewing the ops plan, ops acetabular guide & ops femoral guide.Results: no non-conformance were raised during the design of the acetabular and femoral patient specific guides.The design of the patient specific guides is determined to be unrelated to the failure mode of liner disengaging with the cup.The intended moist heat sterilisation method for sterilizing the ops patient specific instruments has been validated to achieve a sal 10-6 as per iso17665-1.There was no evidence to suggest that the ops technology provided to the primary surgery malfunctioned or was deficient.As per opt-rsk-16 v111, the cleaning and sterilisation parameters have been validated by optimized ortho and deemed adequate to achieve sal 10-6.This failure mode is not associated with the use of ops technology in the primary surgery.Conclusion: there is no evidence to suggest that the ops technology provided to the primary surgery was not manufactured to specification.No non-conformance were raised during the processing of this case.There is no evidence to suggest that the use of ops technology in the primary surgery contributed to this revision event.Please note: the submission of this report does not constitute and admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
 
Event Description
Patient underwent primary procedure for tha on (b)(6) 2018.Patient has recently complained of discomfort.X rays showed evidence that the liner was disengaging with the cup.Therefore, patient underwent revision procedure on (b)(6) 2020.During revision procedure, the surgeon representative found that the patient experienced infection few months after primary procedure and was already revised on (b)(6) 2018.Summary: primary tha procdure: (b)(6) 2018.Revision procdure for infection: (b)(6) 2018.Revision procedure for liner loosening : (b)(6) 2020.During primary procedure , ops technology (ops and ops femoral ) were employed as assistive technology.This event occurred in australia.
 
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Brand Name
CORIN OPTIMIZED POSITIONING SYSTEM
Type of Device
HIP PROSTHESIS
Manufacturer (Section D)
OPTIMIZED ORTHO PTY LTD
17 bridge street
pymble
pymble, nsw 2073
AS  2073
MDR Report Key9679746
MDR Text Key188980155
Report Number3012916784-2020-00053
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
PMA/PMN Number
K152893
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 06/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number1248_0500
Device Lot NumberSCH_SU_12827
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age64 YR
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