OPS
Received Feb 27, 2026 · Event occurred Jan 12, 2026
Report 9614209-2026-00023 · MDR key 24467907
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
62 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
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
SAME DAY REVISION OF HEAD IMPLANT AS WRONG OPS PSI GUIDES WERE USED DURING PRIMARY SURGERY.
Additional Manufacturer Narrative
PER (B)(4) FINAL REPORT: AN INVESTIGATION WAS LAUNCHED INTO THIS EVENT BY THE MANUFACTURER. NO DEVICES WERE RETURNED. THE DEVICE PROCESSING FILES WERE INVESTIGATED WHICH INCLUDED REVIEWING OPS PROCESSES, OPS ACETABULAR AND FEMORAL GUIDES. NO ANOMALIES WERE OBSERVED IN THESE RECORDS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. THE ACETABULAR AND FEMORAL GUIDE DELIVERY PRODUCTS WERE 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. THE REPORTER HAS CONFIRMED THAT THIS EVENT WAS CONTRIBUTED BY THE SCRUB NURSE AT THE HOSPITAL OPENING THE WRONG BOX OF GUIDES. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT HAS NOT BEEN LINKED TO THE DEVICES AND THE ROOT CAUSE OF THIS EVENT IS DEEMED TO BE EXTERNAL. THIS CASE IS NOW CONSIDERED CLOSED. 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
SAME DAY REVISION OF HEAD IMPLANT AS WRONG OPS PSI GUIDES WERE USED DURING PRIMARY SURGERY DUE TO AN ERROR BY THE SCRUB NURSE OPENING THE WRONG BOX OF GUIDES.