ARCOS 12X150MM SPL TPR DIST
Received Sep 1, 2021 · Event occurred Aug 5, 2021
Report 0001825034-2021-02539 · MDR key 12407804
Device
Generic name
Prosthesis Hip
Manufacturer
Zimmer Biomet, Inc.Model number
NICatalog number
11-300812
Lot number
303240
Product problems
- Loss of or Failure to Bond
- Adverse Event Without Identified Device or Use Problem
- Loss of or Failure to Bond
- Adverse Event Without Identified Device or Use Problem
Patient
Female
- Bone Fracture(s)
- Unspecified Infection
- Malunion of Bone
- Bone Fracture(s)
- Unspecified Infection
- Malunion of Bone
Narrative
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
D10: CATALOG#: 11-301300 ARCOS CON SZ A STD 50MM LOT#: 981060. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES MMI:IMPRESSIONS: MODERATE-SIZED PERIPROSTHETIC ZONE OF LUCENCY IN THE RIGHT FEMORAL COMPONENT LOCATED AT THE TROCHANTERIC AND SUBTROCHANTERIC REGION SUGGESTS LOOSENING AND/OR INFECTION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.
Additional Manufacturer Narrative
(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REPORT SOURCE: (B)(6).
Description of Event or Problem
IT WAS REPORTED A PATIENT UNDERWENT HIP REVISION SURGERY APPROXIMATELY 2.5 YEARS POST IMPLANTATION DUE TO INFECTION, PERIPROSTHETIC FRACTURE, MALUNION AND LOOSENING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.