LANTERN HIP
Received May 1, 2025 · Event occurred Apr 3, 2025
Report 3007521480-2025-00012 · MDR key 21942354
Device
Generic name
Surgical Navigation System
Manufacturer
Orthalign, Inc.Model number
502000-01Catalog number
502000-01
Lot number
2502133LS
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE PART WAS RETURNED TO ORTHALIGN FOR INVESTIGATION BY AN ORTHALIGN ENGINEER.THE INVESTIGATION IS IN PROGRESS AND INVESTIGATION CONCLUSIONS ARE NOT AVAILABLE AT THIS TIME. UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED DETAILING THE RESULTS OF THE INVESTIGATION INCLUDING WHETHER OR NOT THE COMPLAINT WAS CONFIRMED AND ANY ROOT CAUSES IDENTIFIED.
Description of Event or Problem
FIRST LL/OS READING: 4 STEM (REAL IMPLANT) WITH +0/36MM HEAD (TRIAL). 3 LONG / 7 MEDIAL. SECOND LL/OS READING: 4 STEM (REAL IMPLANT) WITH +0/36MM HEAD (REAL IMPLANT). 7 LONG / 11 MEDIAL. PERCEPTION THAT THESE NUMBERS SHOULD'VE BEEN SAME AS 1ST READY (3 LONG/7 MEDIAL). THIRD LL/OS READING: NO CHANGE TO IMPLANTS, JUST REDOCKED FS AND RE-DID PROBE IN TACK. 8 LONG / 13 MEDIAL. WOULD NOT HAVE NORMALLY DONE THIS READING, BUT DID IT BECAUSE THE 2ND READING HAD A LARGER DISCREPANCY VS 1ST READING THAN EXPECTED REPORTED READINGS FROM SURGEON. SURGEON'S PRECEPTION IS THAT THE NUMBERS SHOULD HAVE BEEN THE SAME BETWEEN READINGS FOR LEG LENGTH AND OFFSET. CUP ANGLE READINGS WERE AS EXPECTED.
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO ORTHALIGN FOR EVALUATION BY AN ORTHALIGN ENGINEER. THE NAVIGATION LOGS WERE DOWNLOADED AND REVIEWED AND THE TACK REGISTRATION WAS OBSERVED MOVING TO OR AWAY FROM THE LINER REGISTRATION. THE DEVICE PASSED ACCURACY TESTING. THE COMPLAINT WAS CONFIRMED BASED ON THE NAVIGATION LOG DATA. THE ROOT CAUSE WAS NOT DETERMINED. A POSSIBLE ROOT CAUSE IS UNSTABLE ILIAC CREST PINS. ORTHALIGN WILL CONTINUE TO MONITOR SIMILAR EVENTS AND TAKE ACTION IF NECESSARY. NO FURTHER ACTION REQUIRED AT THIS TIME.
Description of Event or Problem
FIRST LL/OS READING: 4 STEMS (REAL IMPLANT) WITH +0/36MM HEAD (TRIAL) 3 LONG / 7 MEDIAL. SECOND LL/OS READING: 4 STEMS (REAL IMPLANT) WITH +0/36MM HEAD (REAL IMPLANT) 7 LONG / 11 MEDIAL. PERCEPTION THAT THESE NUMBERS SHOULD'VE BEEN SAME AS 1ST READY (3 LONG/7 MEDIAL) THIRD LL/OS READING: NO CHANGE TO IMPLANTS, JUST REDOCKED FS AND RE-DID PROBE IN TACK 8 LONG / 13 MEDIAL. WOULD NOT HAVE NORMALLY DONE THIS READING, BUT DID IT BECAUSE THE 2ND READING HAD A LARGER DISCREPANCY VS 1ST READING THAN EXPECTED. REPORTED READINGS FROM SURGEON. SURGEON'S PRECEPTION IS THAT THE NUMBERS SHOULD HAVE BEEN THE SAME BETWEEN READINGS FOR LEG LENGTH AND OFFSET. CUP ANGLE READINGS WERE AS EXPECTED.