FEMORAL MODULAR HEAD - M Ø36MM
Report
- Report Number
- 3008021110-2021-00072
- Event Type
- Injury
- Date Received
- September 8, 2021
- Date of Event
- August 27, 2021
- Report Date
- February 3, 2022
- Manufacturer
- LIMACORPORATE S.P.A.
- Product Code
- LZO
- PMA / PMN Number
- K141327
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BY CHECKING THE DHR OF THE INVOLVED LOTS #2082610 AND #1922200, NO PRE-EXISTING ANOMALY WAS FOUND ON THE ITEMS PLACED ON THE MARKET WITH THE SAME LOT #S. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #S. POST-OPERATIVE X-RAYS WERE SHARED, AND THEY ARE GOING TO BE EVALUATED. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.
BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #2082610, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 100 ITEMS MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST 87 OUT OF 100 FEMORAL HEADS WITH LOT #2082610 - STER. 2100035 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #1922200, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 30 ITEMS MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST 23 OUT OF 30 DELTA LINERS WITH LOT #1922200 - STER. 2000005 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. EXPLANTS ANALYSIS THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS LIMACORPORATE RECEIVED ONE X-RAY REFERRING TO POST-OPERATIVE PREVIOUS SURGERY. X-RAYS PRE-OPERATIVE OF REVISION SURGERY WERE REQUESTED HOWEVER THEY WERE NOT AVAILABLE. THE X-RAY RECEIVED - EXACT DATE NOT KNOWN - HAS BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "SEEMS THE SURGEON BEFORE INDEED HAD IMPLANTED THE CUP TOO VERTICALLY, NOT SURPRISINGLY LEADING TO RECURRENT DISLOCATION. AS I CAN SEE ONLY THE PO XRAY I MAY ONLY COMMENT, THAT THE EXPLANATION OF THE SURGEON APPEARS VERY REASONABLE - AND HE DID AN EXCELLENT JOB WITH THIS KIND OF RECONSTRUCTION". CONSIDERING THAT: CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOTS #2082610 AND #1922200; ACCORDING TO THE SURGEON RESPONSIBLE FOR THE REVISION SURGERY, THE ACETABULAR CUP WAS PLACED TOO VERTICAL DURING PREVIOUS SURGERY ALLOWING THE FEMORAL HEAD TO DISLOCATE; THE MEDICAL CONSULTANT CONFIRMED THE OPINION OF THE SURGEON OPERATING THE REVISION SURGERY, STATING THAT "SEEMS THE SURGEON BEFORE INDEED HAD IMPLANTED THE CUP TOO VERTICALLY, NOT SURPRISINGLY LEADING TO RECURRENT DISLOCATION"; WE CAN STATE THAT THE EVENT WAS SURGEON RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE DUE TO HIP DISLOCATION/LUXATION INVOLVING FEMORAL MODULAR HEADS - BELONGING TO THE FAMILY CODES 5010.42.XXX - IS VERY LOW (< 0.01%). 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.
REVISION SURGERY OF A HIP PROSTHESIS PERFORMED ON (B)(6) 2021, DUE TO IMPLANT DISLOCATION. ACCORDING TO THE REPORTED INFORMATION, SURGEON BELIEVED THE ACETABULAR CUP WAS PLACED TOO VERTICAL DURING PREVIOUS SURGERY ALLOWING THE FEMORAL HEAD TO DISLOCATE. IT WAS REPORTED THAT PATIENT DISLOCATED 7 DAYS AFTER THE PREVIOUS SURGERY, WHICH WAS PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINT SOURCE, PATIENT' HIP WAS REDUCED BACK IN PLACE SOON AFTER DISLOCATING, AND A LIMITING/PROTECTIVE BRACE WAS USED TO REDUCE PATIENT'S RANGE OF MOVEMENT. HOWEVER, THE PATIENT DISLOCATED SOME WEEKS AFTER THE REDUCTION, AND THE REVISION SURGERY WAS DEEMED NECESSARY. THE FOLLOWING COMPONENTS WERE EXPLANTED: FEMORAL MODULAR HEAD - M Ø36MM (PRODUCT CODE 5010.42.362, LOT #2082610 - STER. 2100035). DELTA NEUTRAL LINER ØINT 36MM #L (PRODUCT CODE 5885.51.260, LOT #1922200 - STER. 2000005). REVISION MODULAR NECK H.60MM (PRODUCT CODE 7515.15.010, LOT #2008115 - STER. 2000190). A 20 DEGREE SPACER WAS IMPLANTED TO IMPROVE THE CENTER OF ROTATION IN COMBINATION WITH DUAL MOBILITY LINER TO PREVENT DISLOCATION. PATIENT IS A FEMALE, 71 YEARS OLD. SHE'S A POLIO SUFFERER. IT WAS REPORTED SHE PRACTICES LOW ACTIVITY LEVEL. EVENT HAPPENED IN AUSTRALIA.
REVISION SURGERY OF A HIP PROSTHESIS PERFORMED ON (B)(6), 2021, DUE TO IMPLANT DISLOCATION. ACCORDING TO THE REPORTED INFORMATION, SURGEON BELIEVED THE ACETABULAR CUP WAS PLACED TOO VERTICAL DURING PREVIOUS SURGERY ALLOWING THE FEMORAL HEAD TO DISLOCATE. IT WAS REPORTED THAT PATIENT DISLOCATED 7 DAYS AFTER THE PREVIOUS SURGERY, WHICH WAS PERFORMED ON (B)(6), 2021. ACCORDING TO THE COMPLAINT SOURCE, PATIENT'S HIP WAS REDUCED BACK IN PLACE SOON AFTER DISLOCATING, AND A LIMITING/PROTECTIVE BRACE WAS USED TO REDUCE PATIENT'S RANGE OF MOVEMENT. HOWEVER, THE PATIENT DISLOCATED SOME WEEKS AFTER THE REDUCTION, AND THE REVISION SURGERY WAS DEEMED NECESSARY. THE FOLLOWING COMPONENTS WERE EXPLANTED: FEMORAL MODULAR HEAD - M Ø36MM (PRODUCT CODE 5010.42.362, LOT #2082610 - STER. 2100035) DELTA NEUTRAL LINER ØINT 36MM #L (PRODUCT CODE 5885.51.260, LOT #1922200 - STER. 2000005) REVISION MODULAR NECK H.60MM (PRODUCT CODE 7515.15.010, LOT #2008115 - STER. 2000190) A 20 DEGREE SPACER WAS IMPLANTED TO IMPROVE THE CENTER OF ROTATION IN COMBINATION WITH DUAL MOBILITY LINER TO PREVENT DISLOCATION. PATIENT IS A FEMALE, 71 YEARS OLD. SHE'S A POLIO SUFFERER. IT WAS REPORTED SHE PRACTICES LOW ACTIVITY LEVEL. EVENT HAPPENED IN AUSTRALIA.
BY CHECKING THE DHR OF THE INVOLVED LOT #2082610 AND #1922200, NO PRE-EXISTING ANOMALY WAS FOUND ON THE ITEMS PLACED ON THE MARKET WITH THE SAME LOT #S. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #S. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.
REVISION SURGERY OF A HIP PROSTHESIS PERFORMED ON (B)(6) 2021, DUE TO IMPLANT DISLOCATION. IT WAS REPORTED THAT PATIENT DISLOCATED 7 DAYS AFTER THE PREVIOUS SURGERY. IT WAS REPORTED THAT THE PATIENT' HIP WAS REDUCED HIP BACK IN PLACE AND A LIMITING/PROTECTIVE BRACE WAS USED TO REDUCE THE RANGE OF MOVEMENT. THE PATIENT THEN DISLOCATED SOME WEEKS LATER. ACCORDING TO THE REPORTED INFORMATION, SURGEON BELIEVED THE ACETABULAR CUP WAS PLACED TOO OPEN/VERTICAL DURING PREVIOUS SURGERY ALLOWING THE FEMORAL HEAD TO DISLOCATE. THE FOLLOWING COMPONENTS WERE EXPLANTED: FEMORAL MODULAR HEAD - M Ø36MM (PRODUCT CODE 5010.42.362, LOT #2082610 - STER. 2100035) DELTA NEUTRAL LINER ØINT 36MM #L (PRODUCT CODE 5885.51.260, LOT #1922200 - STER. 2000005) REVISION MODULAR NECK H.60MM (PRODUCT CODE 7515.15.010, LOT #2008115 - STER. 2000190) A 20 DEGREE SPACER WAS IMPLANTED TO IMPROVE CENTER OF ROTATION IN COMBINATION WITH DUAL MOBILITY LINER TO PREVENT DISLOCATION. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2021. PATIENT IS A FEMALE, (B)(6). SHE'S A POLIO SUFFERER. IT WAS REPORTED SHE PRACTICES LOW ACTIVITY LEVEL. EVENT HAPPENED IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1339284 | FEMORAL MODULAR HEAD - M Ø36MM | BIOLOX DELTA HEAD 36MM #M | LZO | LIMACORPORATE S.P.A. | 5010.42.362 | 2082610 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |