ARCOS CON SZ B HI 60MM
Report
- Report Number
- 0001825034-2025-02986
- Event Type
- Injury
- Date Received
- September 23, 2025
- Date of Event
- September 5, 2024
- Report Date
- January 15, 2026
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- KWA
- UDI-DI
- 00880304474093
- PMA / PMN Number
- K090757
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D4; H2; H4; H6. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PATIENT HAD LEFT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE FOLLOWED BY A REVISION DUE TO INFECTION. DURING THE REVISION A TROCHANTERIC FRACTURE WAS FOUND AND A LARGE PLATE AND BOLT WERE PLACED ALONG WITH CERCLAGE CABLES FOR FIXATION. SUBSEQUENTLY THE PATIENT BEGAN EXPERIENCING PAIN AND SWELLING. PATIENT UNDERWENT A PROCEDURE FOR POSSIBLE REMOVAL. DURING THE PROCEDURE THE SCREW WAS SEEN TO BE STILL IN PLACE BUT COMPLETELY LOOSE. THE SCREW WAS REMOVED. THE PLATE IS STILL WELL FIXED AND THEREFORE WAS NOT REMOVED. AN X-RAY IMAGE WAS REVIEWED AND NOT SUBMITTED TO RADIOLOGY AS THE TIMEFRAME DOES NOT ALIGN WITH THE ALLEGATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B1, B3, B5, D6, H1, H2, H6.
(B)(4). G2 FOREIGN: NETHERLANDS. H6 PROPOSED COMPONENT CODE: MECHANICAL (G04) - STEM THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE REMAINS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED A PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE FOLLOWED BY A REVISION DUE TO INFECTION. DURING THE REVISION, A TROCHANTERIC FRACTURE WAS FOUND AND A LARGE PLATE AND BOLT WERE PLACED, ALONG WITH CERCLAGE CABLES FOR FIXATION. SUBSEQUENTLY, THE PATIENT BEGAN TO EXPERIENCE PAIN AND SWELLING APPROXIMATELY NINE (9) MONTHS LATER, UNDERWENT A PROCEDURE FOR POSSIBLE REMOVAL. DURING THE PROCEDURE, THE SCREW WAS FOUND COMPLETELY LOOSE, THE PLATE WAS WELL FIXED, AND A PROXIMAL CERCLAGE WAS BROKEN. THE BOLT WAS REMOVED AND THE PLATE WAS RETAINED.
IT WAS REPORTED THAT A PATIENT UNDERWENT A CASE WHERE ARCOS PROSTHESIS WAS IMPLANTED AND AN ARCOS TROCHANTERIC CLAW WAS USED. THE TROCANTERIC BOLT THAT IS USED TO FIX THE CLAW TO THE PROXIMAL BODY HAS POST OPERATIVELY BACKED OUT OF THE SCREW HOLE. THE BOLT AND CLAW ARE STILL SOMEWHAT IN PLACE, ALTHOUGH THE BOLT HAS BACKED OUT A BIT. THE DEVICES ARE STILL IN SITU IN THIS PATIENT. THERE IS NO SURGERY DATE OF THE REMOVAL OF THESE ITEMS. TROCHANTERIC BOLT IS BACKING OUT OF THE ARCOS CONE PROXIMAL BODY, WHICH CAUSES LOOSENING OF THE ARCOS TROCHANTERIC CLAW. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 734011 | ARCOS CON SZ B HI 60MM | PROSTHESIS, HIP | KWA | ZIMMER BIOMET, INC. | 66241730 | 00880304474093 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Hospitalization| R | BIOMET ARCOS STEM.ITEM: 11300916 LOT: 66552441. |