OPS
Received Feb 27, 2026 · Event occurred Jan 28, 2026
Report 9614209-2026-00021 · MDR key 24466029
Device
Generic name
Orthopaedic Surgical Planning And Instrument Guides
Manufacturer
Corin Ltd.Model number
1250-0100Lot number
DYY_YK_67359
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
68 YR · Male
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
PER (B)(4) FINAL REPORT . AN INVESTIGATION WAS LAUNCHED INTO THIS EVENT BY THE MANUFACTURER. NO DEVICE WAS RETURNED. THIS EVENT WAS CONFIRMED AS SURGICAL INTERVENTION WAS REQUIRED IN ORDER TO PREVENT FURTHER PATIENT HARM FROM PROSTHETIC JOINT INFECTION. THE DEVICE PROCESSING FILES WERE INVESTIGATED WHICH INCLUDED REVIEWING OPS PROCESSES, AND OPS FEMORAL GUIDE. NO ANOMALIES WERE OBSERVED IN THESE RECORDS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. THE FEMORAL GUIDE DELIVERY PRODUCT WAS DESIGNED WITHIN SPECIFICATION. THE OCCURRENCE OF THIS EVENT HAS BEEN DEEMED UNRELATED TO THE USE OF OPS TECHNOLOGY AS THERE WAS NO EVIDENCE TO SUGGEST THAT THE OPS TECHNOLOGY PROVIDED TO THE PRIMARY SURGERY MALFUNCTIONED OR WAS DEFICIENT. NO FURTHER ACTIONS ARE NECESSARY AND THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE IS SYSTEMATIC. THIS ISSUE WILL CONTINUE TO BE MONITORED FOR RECURRENCE. BASED ON THE ABOVE, THE ROOT CAUSE OF THIS EVENT REMAINS UNDETERMINED AND THE MANUFACTURER NOW CONSIDERS THIS CASE CLOSED. SHOULD ANY FURTHER INFORMATION BE MADE AVAILABLE IN THE FUTURE WHICH ALLOWS THE MANUFACTURER TO DETERMINE THE ROOT CAUSE OF THIS EVENT, THIS CASE MAYBE RE-OPENED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE 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. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.
Description of Event or Problem
REVISION DUE TO INFECTION.
Additional Manufacturer Narrative
WE ARE CURRENTLY IN THE PROCESS OF RETRIEVING FURTHER INFORMATION TO PERFORM INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE 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. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.
Description of Event or Problem
REVISION DUE TO INFECTION.