ARCOS MODULAR REVISION HIP SYSTEM
Report
- Report Number
- 0001825034-2025-02836
- Event Type
- Injury
- Date Received
- September 9, 2025
- Date of Event
- September 5, 2025
- Report Date
- January 21, 2026
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- KWA
- UDI-DI
- 00880304474208
- PMA / PMN Number
- K090757
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B5; B7; D6; G3; H2; H6 CLINICAL. THE FOLLOWING SECTIONS WERE CORRECTED: H6 IMPACT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
(B)(4). D10: CAT: 11-301816 LOT: 128460 ARCOS 16X200MM INTLKNG DIST. CAT: 166067 LOT: 6130827 ARCOS DISTAL SCREW TI 5X35MM. G2: FOREIGN ¿ THE NETHERLANDS. H6: SUGGESTED COMPONENT CODE: MECHANICAL (G04) - STEM. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3; H2; H3; H6; H10. THE FOLLOWING SECTIONS WERE CORRECTED: B3; H4. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE BOLT VISUALLY APPEARS TO BE IN GOOD COSMETIC CONDITION, THERE ARE MINOR SCRATCHES AROUND THE MID SHAFT DIAMETER. NO OTHER DAMAGE WAS NOTED DURING VISUAL EVALUATION. THE DIMENSIONS OF THE LENGTH OF THE BOLT AND TIP LENGTH WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THIS DEVICE HAS AN APPROXIMATE IMPLANTATION AGE OF 6 YEARS. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED. REVIEW IDENTIFIED THE FOLLOWING: PATIENT HAD AN INITIAL LEFT THA WITH UNKNOWN PRODUCTS. PATIENT UNDERWENT A TWO STAGE REVISION DUE TO INFECTION. DURING THE STAGE 2 PROCEDURE, A TROCHANTERIC MINOR AND MAJOR WERE FOUND FRACTURED AND NEW ARCOS IMPLANTS WERE PLACED ALONG WITH ARCOS CLAW, BOLT AND NEW CERCLAGE WIRES. OPERATIVE NOTES INDICATE THERE IS GOOD STABILITY AND FUNCTION. THE PATIENT HAD AN ADDITIONAL PROCEDURE DUE TO THE TROCHANTERIC BOLT BACKING OUT OF THE SCREW HOLE. THE BOLT AND CLAW WERE REMOVED. NO OPERATIVE RECORDS WERE PROVIDED FOR THIS PROCEDURE. AN X-RAY IMAGE WAS PROVIDED, HOWEVER WAS NOT FURTHER REVIEWED AS THE IMAGE DOES NOT PROVIDE A CLEAR VIEW OF THE BOLT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. COMPLAINT IS NOT CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED THAT APPROXIMATELY SIX YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A LEFT HIP PROCEDURE DUE TO THE TROCHANTERIC BOLT BACKING OUT OF THE SCREW HOLE THAT IS USED TO SECURE THE TROCHANTERIC CLAW TO THE PROXIMAL BODY AND PAIN. THE BOLT AND CLAW WERE REMOVED AND NOT REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION DUE TO THE TROCHANTERIC BOLT BACKING OUT OF THE SCREW HOLE THAT IS USED TO SECURE THE TROCHANTERIC CLAW TO THE PROXIMAL BODY. IT HAS NOT BEEN CONFIRMED WHICH COMPONENTS WERE REVISED, BUT A SCREW WAS REMOVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 386883 | ARCOS MODULAR REVISION HIP SYSTEM | PROSTHESIS, HIP | KWA | ZIMMER BIOMET, INC. | 931680 | 00880304474208 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H |