CORIN OPTIMIZED POSITIONING SYSTEM

Report

Report Number: 3012916784-2019-00035
Event Type: Malfunction
Date Received: December 11, 2019
Date of Event: November 28, 2019
Report Date: January 17, 2020
Manufacturer: OPTIMIZED ORTHO PTY LTD
Product Code: LZO
PMA / PMN Number: K183038
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

THE OPS PLAN (K183038) AND PSV (K152893) REPORTS WERE GENERATED WITH AN INCORRECT ACETABULAR ORIENTATION AND SENT TO THE SURGEON, HAVING BEEN BASED ON AN INCORRECT DHA REPORT. THIS INCORRECT DHA REPORT EMPLOYED THE USE OF THE INCORRECT STEP UP FUNCTIONAL X-RAY FROM THE CONTRALATERAL SIDE, RESULTING IN THE DYNAMIC ANALYSIS PRODUCED NOT BEING ACCURATE TO THE PATIENT'S ACTUAL HIP MECHANICS. THE DYNAMIC HIP ANALYSIS (DHA) REPORT IS NOT AVAILABLE ON THE US MARKET, HOWEVER THE SIMILAR PRODUCT FUNCTIONAL HIP ANALYSIS (FHA) REPORT (K152893) IS AVAILABLE ON THE US MARKET. THE OPS REPORTS EMAIL USED TO DELIVER THE OPS REPORTS CONTAINED THE CORRECT ACETABULAR ORIENTATION. THIS ISSUE WAS DETECTED PRIOR TO THE POINT OF USE OF THE DEVICE AND THE REPORTS WERE CORRECTED AND RESENT UPON DETECTION OF THE ISSUE. THERE IS NO EVIDENCE THAT THE PATIENT WAS AFFECTED BY THIS ISSUE. A ROOT CAUSE INVESTIGATION HAS BEEN CONDUCTED INTO THIS EVENT. IT WAS DETERMINED THAT DURING THE PROCESSING OF THIS CASE, A SERIES OF MINOR INTERNAL OPERATOR ERRORS LED TO THE INCORRECT GENERATION, UPLOAD AND SENDING OF THE REPORTS INTENDED FOR THE SURGEON. THIS ISSUE WAS DETECTED PRIOR TO THE POINT OF USE AND WAS CORRECTED. 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. 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.

Description of Event or Problem · 0

THE OPS PLAN (K183038) AND PSV (K152893) REPORTS WERE GENERATED WITH AN INCORRECT ACETABULAR ORIENTATION AND SENT TO THE SURGEON, HAVING BEEN BASED ON AN INCORRECT DHA REPORT. THIS INCORRECT DHA REPORT EMPLOYED THE USE OF THE INCORRECT STEP UP FUNCTIONAL X-RAY FROM THE CONTRALATERAL SIDE, RESULTING IN THE DYNAMIC ANALYSIS PRODUCED NOT BEING ACCURATE TO THE PATIENT'S ACTUAL HIP MECHANICS. THE DYNAMIC HIP ANALYSIS (DHA) REPORT IS NOT AVAILABLE ON THE US MARKET, HOWEVER THE SIMILAR PRODUCT FUNCTIONAL HIP ANALYSIS (FHA) REPORT (K152893) IS AVAILABLE ON THE US MARKET. THE OPS REPORTS EMAIL USED TO DELIVER THE OPS REPORTS CONTAINED THE CORRECT ACETABULAR ORIENTATION. THIS ISSUE WAS DETECTED PRIOR TO THE POINT OF USE OF THE DEVICE AND THE REPORTS WERE CORRECTED AND RESENT UPON DETECTION OF THE ISSUE. THERE IS NO EVIDENCE THAT THE PATIENT WAS AFFECTED BY THIS ISSUE. A ROOT CAUSE INVESTIGATION HAS BEEN CONDUCTED INTO THIS EVENT. IT WAS DETERMINED THAT DURING THE PROCESSING OF THIS CASE, A SERIES OF MINOR INTERNAL OPERATOR ERRORS LED TO THE INCORRECT GENERATION, UPLOAD AND SENDING OF THE REPORTS INTENDED FOR THE SURGEON. THIS ISSUE WAS DETECTED PRIOR TO THE POINT OF USE AND WAS CORRECTED. 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.

Additional Manufacturer Narrative · 1

THE OPS PLAN (K183038) AND PSV (K152893) REPORTS WERE GENERATED WITH AN INCORRECT ACETABULAR ORIENTATION AND SENT TO THE SURGEON, HAVING BEEN BASED ON AN INCORRECT DHA REPORT. THIS INCORRECT DHA REPORT EMPLOYED THE USE OF THE INCORRECT STEP UP FUNCTIONAL X-RAY FROM THE CONTRALATERAL SIDE, RESULTING IN THE DYNAMIC ANALYSIS PRODUCED NOT BEING ACCURATE TO THE PATIENT'S ACTUAL HIP MECHANICS. THE DYNAMIC HIP ANALYSIS (DHA) REPORT IS NOT AVAILABLE ON THE US MARKET, HOWEVER THE SIMILAR PRODUCT FUNCTIONAL HIP ANALYSIS (FHA) REPORT (K152893) IS AVAILABLE ON THE US MARKET. THE OPS REPORTS EMAIL USED TO DELIVER THE OPS REPORTS CONTAINED THE CORRECT ACETABULAR ORIENTATION. THIS ISSUE WAS DETECTED PRIOR TO THE POINT OF USE OF THE DEVICE AND THE REPORTS WERE CORRECTED AND RESENT UPON DETECTION OF THE ISSUE. THERE IS NO EVIDENCE THAT THE PATIENT WAS AFFECTED BY THIS ISSUE. 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. 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.

Description of Event or Problem · 1

THE OPS PLAN (K183038) AND PSV (K152893) REPORTS WERE GENERATED WITH AN INCORRECT ACETABULAR ORIENTATION AND SENT TO THE SURGEON, HAVING BEEN BASED ON AN INCORRECT DHA REPORT. THIS INCORRECT DHA REPORT EMPLOYED THE USE OF THE INCORRECT STEP UP FUNCTIONAL X-RAY FROM THE CONTRALATERAL SIDE, RESULTING IN THE DYNAMIC ANALYSIS PRODUCED NOT BEING ACCURATE TO THE PATIENT'S ACTUAL HIP MECHANICS. THE DYNAMIC HIP ANALYSIS (DHA) REPORT IS NOT AVAILABLE ON THE US MARKET, HOWEVER THE SIMILAR PRODUCT FUNCTIONAL HIP ANALYSIS (FHA) REPORT (K152893) IS AVAILABLE ON THE US MARKET. THE OPS REPORTS EMAIL USED TO DELIVER THE OPS REPORTS CONTAINED THE CORRECT ACETABULAR ORIENTATION. THIS ISSUE WAS DETECTED PRIOR TO THE POINT OF USE OF THE DEVICE AND THE REPORTS WERE CORRECTED AND RESENT UPON DETECTION OF THE ISSUE. THERE IS NO EVIDENCE THAT THE PATIENT WAS AFFECTED BY THIS ISSUE. 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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1250262	CORIN OPTIMIZED POSITIONING SYSTEM	HIP PROSTHESIS	LZO	OPTIMIZED ORTHO PTY LTD		LAM_MS_20459

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR