S-ROM M HEAD 36MM +0
Report
- Report Number
- 1818910-2014-18359
- Event Type
- Injury
- Date Received
- May 8, 2014
- Report Date
- September 3, 2014
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- JDI
- PMA / PMN Number
- PK851422
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. PER WI-3430, A REVIEW OF THE DEVICE HISTORY RECORDS IS NO LONGER REQUIRED FOR THE PROVIDED PRODUCT AND LOT COMBINATIONS. ADDITIONAL MEDICAL RECORDS WERE OBTAINED AND REVIEWED BY A MEDICAL PROFESSIONAL. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.
PATIENT CONTACTED DEPUY (LEGAL) INDICATING HE HAS BILATERAL, PINNACLE METAL ON METAL HIPS. THIS COMPLAINT IS FOR THE PATIENT'S RIGHT HIP. RIGHT HIP HAD A CYST DRAINED. THE PATIENT FURTHER INDICATES HIS CURRENT SURGEON TOLD HIM HE DOES NOT NEED SURGERY IMMEDIATELY BUT AN MRI INDICATES HE MAY BE EXPERIENCING BONE LOSS AND WILL NEED REVISION OF BOTH HIPS. ADDITIONALLY, BLOOD TESTING WAS DONE AND HE CURRENTLY HAS "NO COBALT OR CHROMIUM IN HIS BLOOD". UPDATE REC'D 2/18/2014- MEDICAL RECORDS RECEIVED. A CORRECT DOI WAS GIVEN. UPDATE 03/6/2014 - MEDICAL RECORDS RECEIVED. UPDATE REC'D 04/18/2014 - THE COMPLAINT HAS BEEN UPDATED AND CHANGED FROM MDR-NO TO MDR-YES BECAUSE IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED ON (B)(6) 2014 TO ADDRESS DISCOMFORT. SIGNS OF METALLOSIS AND LOCAL TISSUE REACTION WERE FOUND, AS WELL AS OSTEOLYSIS. PART/LOT INFORMATION WAS PROVIDED. 5/8/14. DOI: (B)(6) 2006 - DOR (B)(6) 2014 (RIGHT HIP). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FOUND OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS. PER WI-3430, A REVIEW OF THE DEVICE HISTORY RECORDS IS NO LONGER REQUIRED FOR THESE PRODUCTS. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. MEDICAL RECORDS RECEIVED HAVE BEEN REVIEWED. FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DETERMINE IF THE COMPLAINT IS PRODUCT RELATED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.
ADDITIONAL NARRATIVE: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A COMPLAINT DATABASE SEARCH DID FIND ADDITIONAL RELATED REPORTS AGAINST THE METAL LINER AND/OR FEMORAL HEAD PRODUCT CODE AND LOT NUMBER COMBINATION(S). HOWEVER; A REVIEW OF THE DEVICE HISTORY RECORD(S) ASSOCIATED WITH THIS COMPLAINT WAS NOT REQUIRED PER (B)(4). A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO ADDITIONAL RELATED REPORTS AGAINST THE REMAINING PRODUCT CODE/LOT CODE COMBINATION(S). CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.
EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED OTHER REPORTS AGAINST METAL LINER AND/OR FEMORAL HEAD. PER PROCEDURE, THIS DEVICE(S) IS EXEMPT FROM DEVICE HISTORY RECORD REVIEW. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED NO OTHER REPORTS AGAINST THE REMAINING PRODUCT/LOT CODE COMBINATION. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.
UDI: (B)(4).
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
UDI: (B)(4).
PATIENT CONTACTED DEPUY (LEGAL) INDICATING HE HAS BILATERAL, PINNACLE METAL ON METAL HIPS. THIS COMPLAINT IS FOR THE PATIENT'S RIGHT HIP. RIGHT HIP HAD A CYST DRAINED. THE PATIENT FURTHER INDICATES HIS CURRENT SURGEON TOLD HIM HE DOES NOT NEED SURGERY IMMEDIATELY BUT AN MRI INDICATES HE MAY BE EXPERIENCING BONE LOSS AND WILL NEED REVISION OF BOTH HIPS. ADDITIONALLY, BLOOD TESTING WAS DONE AND HE CURRENTLY HAS "NO COBALT OR CHROMIUM IN HIS BLOOD". HIS PINNACLE IS SCHEDULED TO BE REVISED ON (B)(6) 2014. HOWEVER, IT IS UNKNOWN IF IT IS THE LEFT OR RIGHT HIP OR BOTH HIPS. UPDATE REC'D 2/18/2014- MEDICAL RECORDS RECEIVED. A CORRECT DOI WAS GIVEN. AFTER REVIEW OF THE MEDICAL RECORDS THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 3/10/2014. UPDATE 03/6/2014 - MEDICAL RECORDS RECEIVED. NO NEW INFORMATION RECEIVED THAT WOULD CHANGE THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 03/24/2014. UPDATE REC'D 04/18/2014 - THE COMPLAINT HAS BEEN UPDATED AND CHANGED FROM MDR-NO TO MDR-YES BECAUSE IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED ON 04/18/2014 TO ADDRESS DISCOMFORT. SIGNS OF METALLOSIS AND LOCAL TISSUE REACTION WERE FOUND, AS WELL AS OSTEOLYSIS. PART/LOT INFORMATION WAS PROVIDED. 5/8/2014.
LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PATIENT SUFFERED FROM LARGE AMOUNTS OF COBALT-CHROMIUM METAL ION LEVELS IN THE BLOOD, PAIN, DISCOMFORT, AND INFLAMMATION. THE STEM IS BEING ADDED TO THE COMPLAINT.
PPF ALLEGES PSEUDOTUMOR, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2006; DOR: (B)(6) 2014; (RIGHT HIP).
UPDATE 8/27/15-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED OSTEOLYSIS, CORROSION, AND A FIBROUS NON-UNION OF THE GREATER TROCHANTER CAUSED BY THE OSTEOLYSIS. THERE WAS NO MENTION OF ANY METALLOSIS AS PREVIOUSLY STATED. NO LABS WERE PROVIDED FOR THE ALLEGED HIGH METAL IONS. THE COMPLAINT WAS UPDATED ON:9/23/2015.
PFS ALLEGES EDEMA. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS FAILED RIGHT TOTAL HIP REPLACEMENT. DURING SURGERY, RIGHT AFTER INCISING ILIOTIBIAL BAND, A GROSS AMOUNT OF HEMORRHAGIC FLUID WAS OBTAINED. THE REST OF THE COMPLAINTS WERE ALREADY REPORTED IN THE LEGACY RECORD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 277103 | S-ROM M HEAD 36MM +0 | HIP FEMORAL HEAD | JDI | DEPUY ORTHOPAEDICS INC US | 2128153 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |