32MM DIA COCR MODULAR HEAD -3MM NK
Report
- Report Number
- 0001825034-2012-00504
- Event Type
- Injury
- Date Received
- April 22, 2012
- Date of Event
- August 1, 2012
- Report Date
- March 27, 2012
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- JDI
- PMA / PMN Number
- PK974558
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
THIS FOLLOW-UP REPORT IS BEING FORWARDED TO RELAY NEW INFORMATION ABOUT A REVISION PROCEDURE OF THE MODULAR HEAD AND ACETABULAR SHELL. THIS FOLLOW-UP REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00503-2 / 00504-2).
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY NEW INFORMATION ABOUT A SECOND DISLOCATION AND CLOSED REDUCTION. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00503-1 / 00504-1).
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: "EXCESSIVE ACTIVITY, TRAUMA AND WEIGHT GAIN HAVE BEEN IMPLICATED WITH PREMATURE FAILURE OF THE IMPLANT BY LOOSENING, FRACTURE, AND/OR WEAR." "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00503 / 00504). DEVICE REMAINS IMPLANTED.
REVIEW OF EXPLANTED DEVICES FOUND THAT THE INTERACTIVE SURFACES OF THE ACETABULAR LINER AND MODULAR HEAD WERE WITHIN PRINT SPECIFICATIONS. NO ROOT CAUSE FOR THE RECURRING DISLOCATIONS COULD BE DETERMINED. THIS FOLLOW-UP REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00503-3 / 00504-3 AND 1825034-2012-01329-1).
IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6), 2010. SUBSEQUENTLY, THE PATIENT SUFFERED A FALL ON (B)(6), 2012 AND DISLOCATED THE HIP. A CLOSED REDUCTION PROCEDURE WAS PERFORMED. IT WAS FURTHER REPORTED THAT PATIENT UNDERWENT ANOTHER CLOSED REDUCTION FOLLOWING DISLOCATION ON (B)(6), 2012.
IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, THE PATIENT SUFFERED A FALL ON (B)(6) 2012 AND DISLOCATED THE HIP. A CLOSED REDUCTION PROCEDURE WAS PERFORMED. IT WAS FURTHER REPORTED THAT PATIENT UNDERWENT ANOTHER CLOSED REDUCTION FOLLOWING DISLOCATION ON (B)(6) 2012. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2012, DUE TO INSTABILITY AND RECURRING DISLOCATIONS. THE ACETABULAR LINER AND MODULAR HEAD WERE REMOVED AND REPLACED.
IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, THE PATIENT SUFFERED A FALL ON (B)(6) 2012 AND DISLOCATED THE HIP. A CLOSED REDUCTION PROCEDURE WAS PERFORMED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.
IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, THE PATIENT SUFFERED A FALL ON (B)(6) 2012 AND DISLOCATED THE HIP. A CLOSED REDUCTION PROCEDURE WAS PERFORMED. IT WAS FURTHER REPORTED THAT PATIENT UNDERWENT ANOTHER CLOSED REDUCTION FOLLOWING DISLOCATION ON (B)(6) 2012. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2012, DUE TO INSTABILITY AND RECURRING DISLOCATIONS. THE ACETABULAR LINER, MODULAR HEAD, AND ACETABULAR CUP WERE REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 32MM DIA COCR MODULAR HEAD -3MM NK | PROSTHESIS, HIP | JDI | BIOMET ORTHOPEDICS | N/A | 918780 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |