MODULUS-STRUMENTO-ESTRATTORE
Report
- Report Number
- 3008021110-2022-00064
- Event Type
- Malfunction
- Date Received
- August 9, 2022
- Date of Event
- June 1, 2022
- Report Date
- July 29, 2024
- Manufacturer
- LIMACORPORATE S.P.A.
- Product Code
- JDI
- PMA / PMN Number
- K112158
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT#: 0904786 AND # 1209333, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS MANUFACTURED WITH THE SAME LOT# S. WE WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETED.
INVESTIGATION: CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT NUMBER 0904786, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS MANUFACTURED WITH THE SAME LOT NUMBER. CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT NUMBER 1209333, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS MANUFACTURED WITH THE SAME LOT NUMBER. ACCORDING TO OUR RECORDS, AT LEAST 25 OUT OF 30 MODULUS NECKS L TAPER B 12/14 WITH LOT NUMBER 1209333 AND STERILIZATION NUMBER 1200246 HAVE BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THE LOT NUMBER 1209333. COMPONENTS ANALYSIS: THE INSTRUMENT WAS RECEIVED FOR FURTHER ANALYSIS. THE INTERNAL INSPECTION CONFIRMED THAT THE INSTRUMENT GOT BROKEN BASED ON THE THREAD. WE DIDN'T RECEIVE THE BROKEN PART OF THE THREAD. ACCORDING TO THE INFORMATION RECEIVED BY THE COMPLAINT SOURCE, THE MODULUS MODULAR STEM Ø21 MM (PRODUCT CODE 4310.15.090, LOT NUMBER 1114359) IMPLANTED DURING THE PREVIOUS SURGERY PERFORMED ON (B)(6) 2012, WAS CEMENTED; THIS IS AN OFF-LABEL USE, BECAUSE THE STEM IS INTENDED TO BE USED CEMENTLESS. IN ADDITION, THE EXPLANTED COMPONENTS WERE RETURNED FOR THE INTERNAL ANALYSIS. THE FEMORAL NECK WAS CONFIRMED TO BE STUCK ON THE FEMORAL STEM, AND IT COULDN'T BE DISENGAGED USING THE SUITABLE INSTRUMENTS. THE ITEMS WERE CUT TO INSPECT THEIR INTERNAL SURFACES. THE ANALYSIS REVEALED THAT NO CEMENT IS PRESENT IN BETWEEN THE TWO CONTACTING SURFACES (THE INTERNAL SURFACE OF THE FEMORAL NECK AND THE EXTERNAL SURFACE OF THE FEMORAL STEM TAPER). FRETTING IS FOUND IN BETWEEN THE SURFACES, AND THIS COULD HAVE CONTRIBUTED TO THE DIFFICULTY IN DISENGAGING THE TWO MODULAR COMPONENTS. IN CONCLUSION: NO PRE-EXISTING ANOMALY WAS FOUND ON THE LOT NUMBER 0904786. MOREOVER, IT SHOULD BE CONSIDERED THAT THE INSTRUMENT WAS MANUFACTURED IN 2009. EVEN IF THE NUMBER OF USES IS UNKNOWN, THE INSTRUMENT HAS BEEN ON THE MARKET FOR MORE THAN 10 YEARS. AS PER THE ANALYSIS DESCRIBED ABOVE, WE CAN SUPPOSE THAT THE BREAKAGE OF THE INSTRUMENT IS DUE TO THE EXTRACTION OF THE NECK COUPLED WITH A CEMENTED STEM. INDEED, THE INSTRUMENT IS INTENDED FOR THE EXTRACTION OF THE COMPONENTS IMPLANTED CEMENTLESS, AS PER INTENDED USE. IN ADDITION, THE FRETTING FOUND COULD HAVE CONTRIBUTED TO DIFFICULTY IN THE NECK REMOVAL. WE CAN CONCLUDE THAT THE ISSUE WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, FOR THE INSTRUMENT MODULUS-STRUMENTO-ESTRATTORE WE ESTIMATE AN OCCURRENCE RATE OF BREAKAGE OF THE THREAD TO BE 1.52 %. PLEASE NOTE THAT THIS OCCURRENCE RATE IS OVERESTIMATED BECAUSE IT DOES NOT CONSIDER THE REUSE OF THE INSTRUMENTS BUT ONLY THE TOTAL NUMBER OF PIECES MANUFACTURED. NO SPECIFIC CORRECTIVE ACTION IS NEEDED FOR THIS CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. THIS IS A FINAL REPORT.
CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT NUMBER 0904786, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS MANUFACTURED WITH THE SAME LOT NUMBER. CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT NUMBER 1209333, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS MANUFACTURED WITH THE SAME LOT NUMBER. ACCORDING TO OUR RECORDS, AT LEAST 25 OUT OF 30 MODULUS NECKS L TAPER B 12/14 WITH LOT NUMBER 1209333 AND STERILIZATION NUMBER 1200246 HAVE BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THE LOT NUMBER 1209333. COMPONENTS ANALYSIS: THE INSTRUMENT WAS RECEIVED FOR FURTHER ANALYSIS. THE INTERNAL INSPECTION CONFIRMED THAT THE INSTRUMENT GOT BROKEN AT THE BASE OF THE THREAD. WE DIDN'T RECEIVE THE BROKEN PART OF THE THREAD. ACCORDING TO THE INFORMATION RECEIVED BY THE COMPLAINT SOURCE, THE MODULUS MODULAR STEM Ø21 MM (PRODUCT CODE 4310.15.090, LOT NUMBER 1114359) WAS IMPLANTED CEMENTLESS DURING THE PREVIOUS SURGERY PERFORMED ON NOVEMBER 7TH, 2012, THUS IT WAS USED ON-LABEL. THE EXPLANTED COMPONENTS WERE RETURNED FOR THE INTERNAL ANALYSIS. THE FEMORAL NECK WAS CONFIRMED TO BE STUCK ON THE FEMORAL STEM, AND IT COULDN'T BE DISENGAGED USING THE SUITABLE INSTRUMENTS. THE ITEMS WERE CUT TO INSPECT THEIR INTERNAL SURFACES. THE ANALYSIS REVEALED THAT NO CEMENT IS PRESENT IN BETWEEN THE TWO CONTACTING SURFACES (THE INTERNAL SURFACE OF THE FEMORAL NECK AND THE EXTERNAL SURFACE OF THE FEMORAL STEM TAPER). FRETTING IS FOUND IN BETWEEN THE SURFACES, AND THIS COULD HAVE CONTRIBUTED TO THE DIFFICULTY IN DISENGAGING THE TWO MODULAR COMPONENTS. IN CONCLUSION: NO PRE-EXISTING ANOMALY WAS FOUND ON THE LOT NUMBER 0904786. MOREOVER, IT SHOULD BE CONSIDERED THAT THE INSTRUMENT WAS MANUFACTURED IN 2009. EVEN IF THE NUMBER OF USES IS UNKNOWN, THE INSTRUMENT HAS BEEN ON THE MARKET FOR MORE THAN 10 YEARS. AS PER THE ANALYSIS DESCRIBED ABOVE, WE CAN SUPPOSE THAT THE FRETTING FOUND COULD HAVE CONTRIBUTED TO THE EXPERIENCED DIFFICULTY IN THE NECK REMOVAL; WE CAN CONCLUDE THAT THE ISSUE WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, FOR THE INSTRUMENT MODULUS-STRUMENTO-ESTRATTORE WE ESTIMATE AN OCCURRENCE RATE OF BREAKAGE OF THE THREAD TO BE 1,52 %. PLEASE NOTE THAT THIS OCCURRENCE RATE IS OVERESTIMATED BECAUSE IT DOES NOT CONSIDER THE REUSE OF THE INSTRUMENTS BUT ONLY THE TOTAL NUMBER OF PIECES MANUFACTURED. NO SPECIFIC CORRECTIVE ACTION IS NEEDED FOR THIS CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE.
DURING A REVISION SURGERY OF A HIP IMPLANT PERFORMED ON (B)(6) 2022 (REGISTERED AS COMPLAINT#: (B)(4) AND REPORTED TO THE FDA BY MFR 3008021110-2022-00063), IT WAS IMPOSSIBLE TO REMOVE THE MODULUS NECK L TAPER B 12/14 (PRODUCT CODE: 7595.15.040, LOT#: 1209333 - STER. 1200246) USING THE MODULUS-STRUMENTO-ESTRATTORE (PRODUCT CODE: 9043.10.360, LOT#: 0904786). IT WAS REPORTED THAT WHILE THE HANDLE WAS TURNED THE THREAD OF THE EXTRACTOR BROKE FROM THE ROOT WHEN ADDING FURTHER FORCE. ACCORDING TO THE RECEIVED INFORMATION, IT WAS IMPOSSIBLE TO REMOVE THE BROKEN PART OF THREAD FROM THE NECK'S SCREW, THEREFORE A SECOND NECK EXTRACTOR COULDN'T BE USED. THE NECK AND STEM WERE FIRMLY ATTACHED TO BONE AND COULDN'T BE REMOVE. AFTER WOUND CLOSURE, POST-OPERATIVE X-RAY SHOWED THAT THE DISTAL PART OF THE STEM WAS PROTRUDING OUT OF THE MEDULLARY CAVITY. THE WOUND WAS REOPENED, AND THE SURGEON MANAGED TO REMOVE THE NECK AND THE STEM. PLATE AND WIRE WERE PLACED IN, AND A SECOND REVISION SURGERY IS GOING TO BE PERFORMED AS SOON AS BONE HAS GROWN. IT WAS REPORTED THAT SURGERY GOT PROLONGED BY 9 HOURS DUE TO THE ISSUE. THE NUMBER OF USES OF THE INSTRUMENT IS NOT KNOWN. PATIENT IS A FEMALE. EVENT HAPPENED IN JAPAN.
DURING A REVISION SURGERY OF A HIP IMPLANT PERFORMED ON (B)(6) 2022 (REGISTERED AS COMPLAINT #(B)(4) AND REPORTED TO THE FDA BY MFR 3008021110-2022-00063), IT WAS IMPOSSIBLE TO REMOVE THE MODULUS NECK L TAPER B 12/14 (PRODUCT CODE 7595.15.040, LOT NUMBER 1209333 - STERILIZATION NUMBER 1200246) USING THE MODULUS-STRUMENTO-ESTRATTORE (PRODUCT CODE 9043.10.360, LOT NUMBER 0904786). IT WAS REPORTED THAT WHILE THE HANDLE WAS TURNED THE THREAD OF THE EXTRACTOR BROKE FROM THE ROOT WHEN ADDING FURTHER FORCE. ACCORDING TO THE RECEIVED INFORMATION, IT WAS IMPOSSIBLE TO REMOVE THE BROKEN PART OF THREAD FROM THE NECK'S SCREW, THEREFORE A SECOND NECK EXTRACTOR COULDN'T BE USED. THE NECK AND STEM WERE FIRMLY ATTACHED TO BONE AND COULDN'T BE REMOVE. AFTER WOUND CLOSURE, POST-OPERATIVE X-RAY SHOWED THAT THE DISTAL PART OF THE STEM WAS PROTRUDING OUT OF THE MEDULLARY CAVITY. THE WOUND WAS REOPENED, AND THE SURGEON MANAGED TO REMOVE THE NECK AND THE STEM. PLATE AND WIRE WERE PLACED IN, AND A SECOND REVISION SURGERY IS GOING TO BE PERFORMED AS SOON AS BONE HAS GROWN. IT WAS REPORTED THAT SURGERY GOT PROLONGED BY 9 HOURS DUE TO THE ISSUE. THE NUMBER OF USES OF THE INSTRUMENT IS NOT KNOWN. IT WAS REPORTED THAT THE SURGEON FOLLOWED THE SURGICAL TECHNIQUE. PATIENT IS A FEMALE. EVENT HAPPENED IN JAPAN.
DURING A REVISION SURGERY OF A HIP IMPLANT PERFORMED ON (B)(6) 2022 (REGISTERED AS COMPLAINT #178_22 AND REPORTED TO THE FDA BY MFR 3008021110-2022-00063), IT WAS IMPOSSIBLE TO REMOVE THE MODULUS NECK L TAPER B 12/14 (PRODUCT CODE 7595.15.040, LOT #1209333 - STER. 1200246) USING THE MODULUS-STRUMENTO-ESTRATTORE (PRODUCT CODE 9043.10.360, LOT #0904786). IT WAS REPORTED THAT WHILE THE HANDLE WAS TURNED THE THREAD OF THE EXTRACTOR BROKE FROM THE ROOT WHEN ADDING FURTHER FORCE. ACCORDING TO THE RECEIVED INFORMATION, IT WAS IMPOSSIBLE TO REMOVE THE BROKEN PART OF THREAD FROM THE NECK'S SCREW, THEREFORE A SECOND NECK EXTRACTOR COULDN'T BE USED. THE NECK AND STEM WERE FIRMLY ATTACHED TO BONE. THEN, THE SURGEON PERFORMED AN EXTENDED TROCHANTERIC OSTEOTOMY, IN ORDER TO BE ABLE TO REMOVE THE COMPONENTS. FINALLY, THE STEM AND THE NECK WERE REMOVED, IMPLANTING A CEMENTED STEM OF ANOTHER COMPANY. AFTER WOUND CLOSURE, POST-OPERATIVE X-RAY SHOWED THAT THE DISTAL PART OF THE STEM WAS PROTRUDING OUT OF THE MEDULLARY CAVITY. THE WOUND WAS REOPENED, AND THE SURGEON MANAGED TO REMOVE THIRD PARTY'S STEM AND CEMENT AND PLATE AND WIRE WERE PLACED IN. IT WAS REPORTED THAT SURGERY GOT PROLONGED BY 9 HOURS DUE TO THE ISSUE. THE NUMBER OF USES OF THE INSTRUMENT IS NOT KNOWN. IT WAS REPORTED THAT THE SURGEON FOLLOWED THE SURGICAL TECHNIQUE. PATIENT IS A FEMALE. EVENT HAPPENED IN JAPAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1989122 | MODULUS-STRUMENTO-ESTRATTORE | MODULUS - INSTRUMENTS - NECK EXTRACTOR | JDI | LIMACORPORATE S.P.A. | 9043.10.360 | 0904786 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |