22.2MM DIA COCR MOD HD STD NK
Received May 13, 2014 · Event occurred Apr 28, 2014
Report 0001825034-2014-03927 · MDR key 3808735
Device
Generic name
Prosthesis, Hip
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
163651
Lot number
153180
Product problems
- Insufficient Device Problem Information
Patient
54 YR
- Unspecified Infection
- Pain
- Loss of Range of Motion
- Swelling
- Tissue Damage
- Toxicity
- Osteolysis
- Ambulation or Postural Difficulties
Narrative
Description of Event or Problem
PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2004. LEGAL COUNSEL FURTHER REPORTS PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, LOSS OF RANGE OF MOTION, DAMAGE TO SURROUNDING BONE/TISSUE, LACK OF MOBILITY, ELEVATED METAL ION LEVELS, METAL POISONING, AND METALLOSIS. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, 11. WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 2 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03927 AND 05684).
Description of Event or Problem
PATIENT'S LEGAL COUNSEL REPORTED PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY ON (B)(6) 2004. LEGAL COUNSEL FURTHER REPORTS PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, LOSS OF RANGE OF MOTION, DAMAGE TO SURROUNDING BONE/TISSUE, LACK OF MOBILITY, ELEVATED METAL ION LEVELS, METAL POISONING, AND METALLOSIS. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATE THAT THE RIGHT REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO POLYETHYLENE WEAR. THE PATIENT'S OPERATIVE REPORT NOTED SCAR TISSUE AND REMOVAL OF HEAD, CUP AND LINER. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.
Additional Manufacturer Narrative
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 6 STATES, ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿ NUMBER 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ NUMBER 15 STATES, ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES.¿