FEMORAL MODULAR HEAD - L Ø36MM
Report
- Report Number
- 3008021110-2022-00063
- Event Type
- Injury
- Date Received
- August 9, 2022
- Date of Event
- June 1, 2022
- Report Date
- February 6, 2024
- Manufacturer
- LIMACORPORATE S.P.A.
- Product Code
- LPH
- PMA / PMN Number
- K112158
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #100841, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS MANUFACTURED WITH THE SAME LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT #. WE WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETED.
CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #1008418, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 20 ITEMS MANUFACTURED WITH THE SAME LOT#. ACCORDING TO OUR RECORDS, AT LEAST 13 OUT OF 20 FEMORAL HEADS WITH LOT #1008418 - STER. 1000206 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. DEVICE ANALYSIS PICTURES OF EXPLANTS WERE SHARED. CEMENT IS VISIBLE ON THE SURFACE OF THE FEMORAL STEM AND AT THE JUNCTION BETWEEN THE FEMORAL NECK AND STEM. THE ITEMS INVOLVED WERE RETURNED TO LIMACORPORATE FOR ANALYSIS. A DIMENSIONAL ANALYSIS WAS PERFORMED ON THE RETURNED HEAD, CONFIRMING IT TO BE COMPLIANT TO THE SPECIFICS. X-RAYS ANALYSIS LIMACORPORATE RECEIVED A TOTAL OF TWO X-RAYS REFERRING ONE TO POST-OPERATIVE OF PRIMARY SURGERY AND ONE TO PRE-OPERATIVE OF REVISION SURGERY. THE X-RAYS RECEIVED - DATED (B)(6), 2012, AND (B)(6) 2022 (EXACT DATE NOT KNOWN) - HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THE X-RAY 2012 SHOWS A PERFECTLY CORRECT THR WITH AN UNCEMENTED STEM. THE NEXT X-RAY DATED (B)(6) 2022, SHOWS THE DISLOCATED HIP, HOWEVER WITH A CEMENTED STEM. THAT MEANS THAT BETWEEN THE 2 DATES THERE MUST HAVE BEEN ANOTHER REVISION. THE DISLOCATED HIP, ACCORDING TO YOUR INFO, HAS BEEN REVISED IN (B)(6) 2022, BUT THERE IS NO X-RAY AVAILABLE. TO COMMENT ON POSSIBLE FAILURE, I WOULD NEED AN X-RAY BEFORE MAY AND IF POSSIBLE AFTER (B)(6) 2022". WE CONFIRMED WITH THE COMPLAINT SOURCE THAT THE STEM AND THE NECK WERE CEMENTED UPON IMPLANTING THEM. IN ADDITION, IT WAS CONFIRMED THAT THE COMPONENTS WERE IMPLANTED ON (B)(6), 2012, NO OTHER REVISION SURGERY IN BETWEEN WAS REPORTED. THE MEDICAL EXPERT COULDN'T PERFORM ANY FURTHER ASSESSMENT BASED ON THE PROVIDED INFORMATION. THE MODULUS MODULAR STEM Ø21 MM (PRODUCT CODE 4310.15.090) IS INTENDED TO BE USED CEMENTLESS. INDICATIONS ARE GIVEN ALSO ON THE IMPLANT'S LABEL. THE COMPLAINT SOURCE CONFIRMED THAT THE PROSTHESIS WAS IMPLANTED CEMENTED, THEREFORE OFF-LABEL. CONSIDERING THAT: ACCORDING TO THE RECEIVED INFORMATION, THE DISLOCATION WAS EXPERIENCED WHEN THE PATIENT SQUATTED DOWN DOING FARMING WORKING; · THE PROSTHESIS WAS IMPLANTED ON (B)(6), 2012, AND IT HAS BEEN IN PLACE FOR ABOUT 10 YEARS; THE VISUAL ANALYSIS PERFORMED ON THE SHARED PICTURES SHOWED THAT CEMENT IS PRESENT AT THE JUNCTION BETWEEN THE FEMORAL NECK AND STEM; ACCORDING TO THE MEDICAL EXPERT, NO COMMENT CAN BE MADE ON THE DISLOCATION BASED ON THE PROVIDED RADIOGRAPHS; HOWEVER NO FURTHER INFORMATION WAS AVAILABLE ON THE PROVIDED X-RAYS; WE CANNOT DETERMINE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT THE CHECK OF MANUFACTURING CHARTS OF LOT #1008418 FOUND NO ANOMALIES, AND CONSIDERING THAT THE DIMENSIONAL ANALYSIS PROVED THE FEMORAL HEAD TO BE WITHIN THE SPECIFICS, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. IN ADDITION, THE FEMORAL STEM WAS IMPLANTED OFF-LABEL BY CEMENTING IT. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF FEMORAL HEADS - BELONGING TO THE FAMILY CODES 5010.09.XXX - DUE TO DISLOCATION IS 0.007%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.
CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #1008418, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 20 ITEMS MANUFACTURED WITH THE SAME LOT#. ACCORDING TO OUR RECORDS, AT LEAST 13 OUT OF 20 FEMORAL HEADS WITH LOT #1008418 - STER. 1000206 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. DEVICE ANALYSIS: THE ITEMS INVOLVED WERE RETURNED TO LIMACORPORATE FOR ANALYSIS. A DIMENSIONAL ANALYSIS WAS PERFORMED ON THE RETURNED FEMORAL HEAD, CONFIRMING IT TO BE COMPLIANT TO THE SPECIFICS. THE DIMENSIONAL ANALYSIS WAS AS WELL PERFORMED ON THE CONE OF THE MODULAR NECK, AND IT PROVED THAT NO MEASURE WAS FOUND TO BE OUT OF THE SPECIFICS. X-RAYS ANALYSIS: THE TWO X-RAYS (REFERRING ONE TO POST-OPERATIVE OF THE PRIMARY SURGERY AND ONE TO PRE-OPERATIVE OF THE REVISION SURGERY), AND PICTURES OF THE EXPLANTED MODULUS STEM (BEFORE AND AFTER THE DECONTAMINATION) WERE AGAIN SUBMITTED TO THE MEDICAL CONSULTANT IN LIGHT OF THE ADDITIONAL INFORMATION RECENTLY SHARED. ABOUT THE PICTURES, THE MEDICAL CONSULTANT COMMENTED: "THE FILE "STEM" SHOWS TYPICAL REMNANTS OF BONE ON A WELL-INTEGRATED UNCEMENTED STEM. THERE IS NO SIGN OF ANY CEMENTATION. THIS PART OF THE IMPLANT WAS VERY WELL FIXED. ON THE "DECONTAMINATED" PHOTOS MOST OF THE BONE HAS BEEN REMOVED". THE X-RAYS RECEIVED - DATED (B)(6) 2012, AND (B)(6) 2022 (EXACT DATE UNKNOWN) RESPECTIVELY - HAVE BEEN EVALUATED AGAIN BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "WITHOUT ANY DOUBT THE STEM OF 2012 IS ANOTHER ONE THAN THE ONE 2022. THE 12 ONE IS SHORTER AND UNCEMENTED, THE 22 ONE LONGER AND OBVIOUSLY CEMENTED. SO, IT HAS BEEN EXCHANGED BETWEEN 2012 AND 2022. I PRESUME, THE PHOTOS OF THE EXPLANTS DERIVE FROM THE 2012 STEM (UNCEMENTED). YOU NEED TO FIND OUT WHEN AND HOW THE "2022 STEM" HAS BEEN IMPLANTED AND PROVIDE X-RAYS IMMEDIATELY AFTER IMPLANTATION". WE CONFIRMED WITH THE COMPLAINT SOURCE THAT THE TWO X-RAYS ARE FROM THE SAME PATIENT. MOREOVER, IT WAS CONFIRMED THAT THE STEM AND THE NECK WERE IMPLANTED CEMENTLESS UPON PRIMARY SURGERY ON (B)(6) 2012, AND NO REVISION SURGERY IN BETWEEN WAS REPORTED. ADDITIONAL X-RAYS WERE REQUESTED TO THE COMPLAINT SOURCE, BUT THEY WEREN'T AVAILABLE. THEREFORE, X-RAYS FROM (B)(6) 2022 CANNOT BE USED FOR ANY EVALUATION. THOSE X-RAYS DISPLAY A DIFFERENT IMPLANT (DIFFERENT STEM AND CEMENTED) AND THE MEDICAL EXPERT COULDN'T PERFORM ANY FURTHER ASSESSMENT BASED ON THE PROVIDED INFORMATION. THE MODULUS MODULAR STEM Ø21 MM (PRODUCT CODE 4310.15.090) IS INTENDED TO BE USED CEMENTLESS. INDICATIONS ARE GIVEN ALSO ON THE IMPLANT'S LABEL. THE COMPLAINT SOURCE CONFIRMED THAT THE PROSTHESIS WAS IMPLANTED CEMENTLESS. CONSIDERING THAT: · ACCORDING TO THE RECEIVED INFORMATION, THE DISLOCATION WAS EXPERIENCED WHEN THE PATIENT SQUATTED DOWN DOING FARMING WORKING; · THE PROSTHESIS WAS IMPLANTED ON (B)(6) 2012, AND IT HAS BEEN IN PLACE FOR ABOUT 10 YEARS; · THE VISUAL ANALYSIS PERFORMED ON THE SHARED PICTURES SHOWED JUST THE PRESENCE OF BONE REMNANTS ON THE EXPLANTED MODULUS STEM; · ACCORDING TO THE MEDICAL EXPERT, NO COMMENT CAN BE MADE ON THE DISLOCATION BASED ON THE PROVIDED RADIOGRAPHS; · NO FURTHER X-RAYS WERE AVAILABLE; WE CANNOT DETERMINE THE ROOT CAUSE OF THE EVENT. CONSIDERING THAT THE CHECK OF MANUFACTURING CHARTS OF LOT #1008418 FOUND NO ANOMALIES AND CONSIDERING THAT THE DIMENSIONAL ANALYSIS PROVED THAT THE FEMORAL HEAD AND THE MODULAR NECK ARE WITHIN THE SPECIFICS, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF FEMORAL HEADS - BELONGING TO THE FAMILY CODES 5010.09.XXX - DUE TO DISLOCATION IS 0.007%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.
HIP REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO DISLOCATION. IT WAS REPORTED THAT THE PATIENT SQUATTED DOWN AS SHE WAS DOING FARMING WORK AT THE TIME OF THE DISLOCATION. JUST AFTER, THE PATIENT JUMPED PROBABLY BECAUSE SHE FELT UNUSUAL DUE TO THE DISLOCATION. THE FOLLOWING COMPONENTS WERE EXPLANTED AND REPLACED: FEMORAL MODULAR HEAD - L Ø36MM (PRODUCT CODE 5010.09.363, LOT #1008418 - STER. 1000206); MODULUS MODULAR STEM Ø21 MM (PRODUCT CODE 4310.15.090, LOT #1114359 - STER. 1200131); MODULUS NECK L TAPER B 12/14 (PRODUCT CODE 7595.15.040, LOT #1209333 - STER. 1200246). DURING SURGERY, AN INTRA-OPERATIVE ISSUE WAS EXPERIENCED. IT WAS REGISTERED AS COMPLAINT # (B)(4) AND REPORTED TO THE FDA BY MFR 3008021110-2022-00064. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2012. PATIENT IS A FEMALE. EVENT HAPPENED IN JAPAN.
HIP REVISION SURGERY PERFORMED ON (B)(6), 2022, DUE TO DISLOCATION. IT WAS REPORTED THAT THE PATIENT SQUATTED DOWN AS SHE WAS DOING FARMING WORK AT THE TIME OF THE DISLOCATION. JUST AFTER, THE PATIENT JUMPED PROBABLY BECAUSE SHE FELT UNUSUAL DUE TO THE DISLOCATION. THE FOLLOWING COMPONENTS WERE EXPLANTED AND REPLACED: FEMORAL MODULAR HEAD - L Ø36MM (PRODUCT CODE 5010.09.363, LOT #1008418 - STER. 1000206). MODULUS MODULAR STEM Ø21 MM (PRODUCT CODE 4310.15.090, LOT #1114359 - STER. 1200131). MODULUS NECK L TAPER B 12/14 (PRODUCT CODE 7595.15.040, LOT #1209333 - STER. 1200246). DURING SURGERY, AN INTRA-OPERATIVE ISSUE WAS EXPERIENCED. IT WAS REGISTERED AS COMPLAINT #(B)(4) AND REPORTED TO THE FDA BY MFR 3008021110-2022-00064. IT WAS REPORTED THAT DIFFICULTY WAS ENCOUNTERED IN REMOVING THE STEM, THE NECK AND THE CEMENT, WHICH WERE PLACED IN DURING PRIMARY SURGERY. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2012. PATIENT IS A FEMALE, IN HER LATE 70S. ACCORDING TO THE RECEIVED INFORMATION, PATIENT HAS A BMI OF 26.56, AND PERFORMS A MODERATE ACTIVITY LEVEL. SHE HAS HIGH-BLOOD PRESSURE. EVENT HAPPENED IN JAPAN.
HIP REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO DISLOCATION. IT WAS REPORTED THAT THE PATIENT SQUATTED DOWN AS SHE WAS DOING FARMING WORK AT THE TIME OF THE DISLOCATION. JUST AFTER, THE PATIENT JUMPED PROBABLY BECAUSE SHE FELT UNUSUAL DUE TO THE DISLOCATION. THE FOLLOWING COMPONENTS WERE EXPLANTED AND REPLACED: · FEMORAL MODULAR HEAD - L Ø36MM (PRODUCT CODE 5010.09.363, LOT #1008418 - STER. 1000206). · MODULUS MODULAR STEM Ø21 MM (PRODUCT CODE 4310.15.090, LOT #1114359 - STER. 1200131). · MODULUS NECK L TAPER B 12/14 (PRODUCT CODE 7595.15.040, LOT #1209333 - STER. 1200246). DURING SURGERY, AN INTRA-OPERATIVE ISSUE WAS EXPERIENCED. IT WAS REGISTERED AS COMPLAINT #180_22 AND REPORTED TO THE FDA BY MFR 3008021110-2022-00064. IT WAS REPORTED THAT DIFFICULTY WAS ENCOUNTERED IN REMOVING THE STEM AND THE NECK, WHICH WERE PLACED IN DURING PRIMARY SURGERY. DUE TO THE EVENT, A SECOND REVISION SURGERY WAS PLANNED. ACCORDING TO THE RECEIVED INFORMATION, THE SECOND REVISION SURGERY WAS PERFORMED (DATE NOT KNOWN): A COMPETITOR'S IMPLANT WAS PLACED IN, AND THE PATIENT RECOVERED. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2012. PATIENT IS A FEMALE, IN HER LATE 70S. ACCORDING TO THE RECEIVED INFORMATION, PATIENT HAS A BMI OF 26.56, AND PERFORMS A MODERATE ACTIVITY LEVEL. SHE HAS HIGH-BLOOD PRESSURE. EVENT HAPPENED IN JAPAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2248259 | FEMORAL MODULAR HEAD - L Ø36MM | MODULAR FEMORAL HEADS (COCRMO) DIA. 36MM L TAPER 12/14 | LPH | LIMACORPORATE S.P.A. | 5010.09.363 | 1008418 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |