32MM DIA COCR MOD HEAD +12MM NK
Report
- Report Number
- 0001825034-2014-04409
- Event Type
- Injury
- Date Received
- May 20, 2014
- Date of Event
- July 15, 2013
- Report Date
- February 21, 2018
- Manufacturer
- .
- Product Code
- JDI
- PMA / PMN Number
- PK911684
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
Narratives
THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 1 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-04409 AND 07609 / 07611).
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 10 STATES, "FRETTING AND CREVICE CORROSION CAN OCCUR AT INTERFACES BETWEEN COMPONENTS." NUMBER 11 STATES, ¿WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES.¿ NUMBER 14 STATES, ¿POSTOPERATIVE BONE FRACTURE AND PAIN.¿
(B)(4). THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCTS- PART: PT-116048 NAME: RNGLC+ LTD 48MM SZ 22 LOT: 817600 ; PART: EP-105780 NAME: EPOLY 32MM +5 RGLC LNR HW SZ22 LOT: 571760 ; PART: X11-180308 NAME: BI-METRIC/X POR NC LAT LOT: 144910. THE INVESTIGATION IS STILL IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-06376, 0001825034-2017-06377, 0001825034-2017-06378.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED OP NOTES. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED OP NOTES. BASED ON REVISION OP NOTES, PATIENT WAS INDICATED FOR REVISION DUE TO PAIN AND A POSSIBLY LOOSE ACETABULAR COMPONENT. THE ACETABULAR SCREWS WERE REMOVED AND THE SHELL WAS NOTED TO BE WELL FIXED, HOWEVER, ACETABULAR OSTEOPHYTES, WHICH WERE REMOVED AS THEY WERE BELIEVED TO BE CAUSING IMPINGEMENT LEADING TO PAIN. EVIDENCE OF REPEATED POSTERIOR SUBLUXATION WAS SEEN BY THE WEAR PATTERN ON THE ACETABULAR LINER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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.
LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004 AND RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2003. LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT REVISION PROCEDURE ON (B)(6) 2006 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, AND INFLAMMATION. LEGAL COUNSEL FOR PATIENT FURTHER REPORTS THAT PATIENT UNDERWENT A FURTHER RIGHT REVISION PROCEDURE ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, LACK OF MOBILITY, ELEVATED METAL ION LEVELS, METALLOSIS, FRETTING AND CORROSION. LEGAL COUNSEL ALSO REPORTED THAT PATIENT UNDERWENT A FURTHER RIGHT HIP REVISION PROCEDURE ON (B)(6) 2013 DUE TO UNSPECIFIED COMPLICATIONS. THERE HAS BEEN NO REPORTED LEFT HIP REVISION PROCEDURE TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATES RIGHT TOTAL HIP ARTHROPLASTY WAS PERFORMED ON (B)(6) 2003. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATES RIGHT HIP REVISION PERFORMED ON (B)(6) 2006 WAS DUE TO PAIN AND SUBLUXATION. THE PATIENT'S OPERATIVE REPORT NOTED DECREASED ANTEVERSION OF CUP AND FEMORAL COMPONENT, SYNOVITIS, AND DARK STAINING. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATES RIGHT HIP REVISION PERFORMED ON (B)(6) 2012 WAS DUE TO PAIN. THE PATIENT'S OPERATIVE REPORT NOTED POSSIBLE ADVERSE METAL ION/ADVERSE SOFT TISSUE, AND SYNOVIAL IRRITATION. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS INDICATES RIGHT HIP REVISION PERFORMED ON (B)(6) 2013 WAS DUE TO PAIN. THE PATIENT'S OPERATIVE REPORT NOTED SUSPECTED ANTERIOR IRRITATION DUE TO ANTERIOR OSTEOPHYTES AND IMPINGEMENT OF FEMUR. REVIEW OF INVOICE HISTORY CONFIRMED AN ADDITIONAL RIGHT HIP REVISION PERFORMED ON (B)(6) 2014. ADDITIONAL INFORMATION RECEIVED NOTED THAT ON (B)(6) 2012 AND (B)(6) 2014 PATIENT'S BLOOD WAS TESTED.
LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004 AND RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2003. LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT REVISION PROCEDURE ON (B)(6) 2006 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, AND INFLAMMATION. LEGAL COUNSEL FOR PATIENT FURTHER REPORTS THAT PATIENT UNDERWENT A FURTHER RIGHT REVISION PROCEDURE ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, INFLAMMATION, LACK OF MOBILITY, ELEVATED METAL ION LEVELS, METALLOSIS, FRETTING AND CORROSION. LEGAL COUNSEL ALSO REPORTED THAT PATIENT UNDERWENT A FURTHER RIGHT HIP REVISION PROCEDURE ON (B)(6) 2013 DUE TO UNSPECIFIED COMPLICATIONS. THERE HAS BEEN NO REPORTED LEFT HIP REVISION PROCEDURE TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.
IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO A FAILED TOTAL HIP REVISION WITH SOLIDLY FIXED CUP IN GOOD POSITION WITH ANTERIOT IRRIGATION OF THE PSOAS TENDON AND BURSA DUE TO ANTERIOR OSTEOPHYTES OF THE ACETABULUM AND EARLY IMPINGEMENT OF THE FEMUR AND ANTERVERISION OF THE STEM. CUP WAS WELL FIXED BUT SIGNIFICANT ANTERIOR LEDGE OF BONE AND OSTEOPHYTE OF THE ACETABULUM WAS NOTED. EARLY IMPINGEMENT WA NOTED OF THE STEM AND IT WAS NOTED TO BE IN 7-8 DEGREES OF ANTEVERISION. THE HEAD AND LINER WERE REMOVED AND REPLACED. NO COMPLICATIONS INDICATED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 300085 | 32MM DIA COCR MOD HEAD +12MM NK | PROSTHESIS, HIP | JDI | . | N/A | 188490 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| R |