ML-HD MOD CALC PROX 45B
Report
- Report Number
- 0001825034-2016-00654
- Event Type
- Injury
- Date Received
- February 29, 2016
- Date of Event
- January 6, 2016
- Report Date
- January 22, 2018
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- LPH
- PMA / PMN Number
- PK031693
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 9 STATES, "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT." NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-04812 / 04813 & 1825034-2016-00654).
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: CER BIOLOXD OPTION HD 40 MM P/N 650-1058 L/N 813420, CER OPTION TYPE 1 TPR SLEVE +3 P/N 650-1067 L/N 821660, E-POLY 40 MM +3 HIWALL LNR SZ25 P/N EP-108525 L/N 778630, REGEN/RNGLC+ MULTI 62 MM SZ 25 P/N PT-106062 L/N 325890, TI LOW PROFILE SCREW 103533 LOT 008890, R/H M/H 11X220 80% 11-108251 LOT 519410. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS AND OP NOTES. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. REVIEW OF SECOND REVISION OP NOTES STATES PATIENT UNDERWENT RIGHT HIP ARTHROPLASTY WITH BROKEN RIGHT PROXIMAL FEMORAL STEM. X-RAYS WERE PROVIDED BUT THE DATE THEY WERE TAKEN WAS UNKNOWN. REVIEW OF X-RAYS BY RADIOLOGIST IDENTIFIED A FRACTURE OF THE PROXIMAL SUB TROCHANTERIC REGION OF THE STEM WITH PROBABLY 4-5 MM DISTRACTION OF THE FRACTURED ENDS. THE FRACTURE RESULTS IN VARUS ANGULATION OF THE FEMORAL COMPONENT AND CONTACT OF THE FEMORAL HEAD COMPONENT SLIGHTLY INFERIORLY WITH THE ACETABULAR CUP. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN THE ASSOCIATED RISK DOCUMENTATION. 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 PATIENT UNDERWENT TOTAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2010 DUE TO PAIN, METAL DEBRIS, AND AUDIBLE SQUEAKING OF IMPLANTS. IT WAS FURTHER REPORTED A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2016 DUE TO CALCAR FRACTURE. THE MALLORY HEAD CALCAR WAS REMOVED AND REPLACED.
IT WAS REPORTED A PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY EIGHT YEARS POST-IMPLANTATION DUE TO CALCAR FRACTURE. THE HEAD AND CALCAR COMPONENT WERE REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 125297 | ML-HD MOD CALC PROX 45B | PROSTHESIS, HIP | LPH | BIOMET ORTHOPEDICS | N/A | 533200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Hospitalization| R |