0001825034-2018-06038
Report
- Report Number
- 0001825034-2018-06038
- Event Type
- Injury
- Date Received
- August 6, 2018
- Date of Event
- January 22, 2014
- Report Date
- November 9, 2018
- PMA / PMN Number
- PK090757
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS : PT-106056, REGEN/RNGLC+ MULTI, 150750, 11-107323, FREEDOM STD FACE LINER, 363880, 11-107018, FREEDOM CONSTRAINED HEAD, 968260, 103531, TI LOW PROFILE SCREW, 930580, 11-301312, ARCOS CON, 491000, 120002, COCR TROCH CABLE, 516680 (QTY 2), 120005, COCR CABLE SLEEVE, 609390 (QTY 5). INFORMATION RECEIVED DOES NOT CHANGE THE PREVIOUSLY SUBMITTED INVESTIGATION. 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.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
(B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: 11-301312 - ARCOS CON SZ B HI 60MM ¿ 491000; UNKNOWN - REGENEREX RINGLOC MULTIHOLE ¿ UNKNOWN; UNKNOWN - FREEDOM RINGLOC CONSTRAINED ¿ UNKNOWN. UNKNOWN - FREEDOM CONSTRAINED TYPE I TAPER ¿ UNKNOWN. THERAPY DATE: (B)(6) 2014. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE LOCATION OF THE DEVICE IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY 3 YEARS POST RIGHT HIP REVISION SURGERY DUE TO DISTAL FEMORAL FRACTURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Hospitalization| R |