12/14 ARTICUL 44MM M SPEC+1.5
Report
- Report Number
- 1818910-2023-03889
- Event Type
- Injury
- Date Received
- February 16, 2023
- Date of Event
- March 4, 2021
- Report Date
- February 16, 2023
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- LPH
- UDI-DI
- 10603295034032
- PMA / PMN Number
- K060031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED. H10 ADDITIONAL NARRATIVE: ADDED: A2 (DOB), A3, B5, B6, B7, D4, E3, G4, H4, H6 (CLINICAL CODES). E3 INITIAL REPORTER OCCUPATION: LAWYER. H6 CLINICAL CODE: METAL RELATED PATHOLOGY (E1618) IS USED TO CAPTURE METAL POISONING AND BLOOD HEAVY METAL INCREASED. CORRECTED: A1, D1, D2A, D2B, D10.
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
ON (B)(6) 2021 A MEDICAL EXAMINER CONFIRMED DURING THIS VISIT THAT ON (B)(6) 2021, THAT THE PATIENT HAD UNDERWENT EXCISIONAL RIGHT HIP ARTHROPLASTY, FOR RECENTLY PLACED RIGHT THA BECAUSE OF WOUND INFECTION, ANTIBIOTIC SPACER PLACED. DOI: (B)(6) 2009. DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT HIP.
MOM PINNACLE LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES HEAVY METAL POISONING FROM TOXIC HEAVY METAL RESULTING TO INJURY TO HER MUSCLE, TISSUE, SCAR TISSUE FORMATION, PAIN, METAL WEAR, LOSS OF ENJOYMENT OF LIFE, LIMITED ADL, EMOTIONAL TRAUMA AND DISTRESS. DOI: (B)(6) 2009. DOR: (B)(6) 2021 . RIGHT HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1972833 | 12/14 ARTICUL 44MM M SPEC+1.5 | ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS | LPH | DEPUY ORTHOPAEDICS INC US | 1365-61-000 | 3023704 | 10603295034032 |
| 354876 | 12/14 ARTICUL 44MM M SPEC+1.5 | ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS | LPH | DEPUY ORTHOPAEDICS INC US | 1365-61-000 | 3023704 | 10603295034032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female | Required Intervention | PINN CAN BONE SCREW 6.5MMX20MM| PINNACLE MTL INS NEUT36IDX54OD| PINNACLE SECTOR II CUP 54MM| SUMMIT POR TAPER SZ4 STD OFF| UNK HIP ACETABULAR CUP PINNACLE| UNK HIP ACETABULAR LINER METAL PINNACLE| UNK HIP FEMORAL HEAD METAL| UNKNOWN HIP FEMORAL STEM |