MOBILE LINER INT 28 MM 42 MM

Report

Report Number: 3008021110-2021-00031
Event Type: Injury
Date Received: April 16, 2021
Date of Event: April 2, 2021
Manufacturer: LIMACORPORATE SPA
Product Code: LZO
PMA / PMN Number: K181491
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

BY CHECKING THE DHR OF THE LOT #20AT020, NO PRE-EXISTING ANOMALIES WERE DETECTED ON THE MOBILE LINERS MANUFACTURED WITH THE SAME LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT#. LIMACORPORATE RECEIVED ONE X-RAYS IMAGE TAKEN IN (B)(6) 2021 (EXACT DATE IS UNKNOWN). THIS IMAGE WAS SHARED WITH OUR MEDICAL CONSULTANT FOR A CLINICAL EVALUATION. HE COMMENTED THE FOLLOWING: "ON THIS X-RAY INDEED THE METAL HEAD SEEMS TO BE OUT OF THE POLY LINER AND NOW SEEMS TO ARTICULATE WITH THE METAL INLAY. MAYBE DUE TO SOME MISMATCH OF DIFFERENT MANUFACTURERS. STILL THE METAL LINER DEFINITIVELY HAS ALSO DISLOCATED OUT OF THE CUP. THERE MIGHT BE AN ALTERNATIVE INTERPRETATION OF THE PICTURE: AS ONLY ONE PLANE IS DEPICTED IT IS NOT POSSIBLE TO ESTIMATE THE EXACT POSITION OF THE HEAD. IT MIGHT BE POSITIONED ALSO IN FRONT OR BEHIND THE CUP! IN ANY CASE THERE IS A DISLOCATION, BUT NOT ONLY OF ONE COMPONENT BUT BOTH HEAD, LINER AND METAL COUPLING." NEVERTHELESS, THE COMPLAINT SOURCE CONFIRMED THAT THERE WAS NO DISLOCATION OF THE LINER, BUT ONLY OF THE METAL HEAD FROM THE POLYETHYLENE LINER. AFTER THE EVALUATION OF OUR MEDICAL CONSULTANT, THE DEVICE HISTORY RECORDS OF THE LINER FOR DUAL MOBILITY (PRODUCT CODE 5885.09.042, LOT 2012303) WERE ALSO CHECKED, AND NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS PLACED ON THE MARKET WITH THE SAME LOT#. AS ONLY THE POLYETHYLENE LINER AND THE METAL HEAD WERE RETURNED, NO ADDITIONAL ANALYSIS COULD BE PERFORMED ON THE METAL LINER. THE USE OF FEMORAL HEADS FROM DIFFERENT MANUFACTURERS IN COMBINATION WITH LIMA DELTA ACETABULAR SYSTEM IN NOT ALLOWED: THE INSTRUCTION FOR USE OF THE DELTA SYSTEM CLEARLY SPECIFIES THAT "THE COMPONENTS OF DELTA ACETABULAR SYSTEM MUST NOT BE USED OUTSIDE THE ALLOWED COMBINATIONS OR WITH COMPONENTS BELONGING TO OTHER MANUFACTURERS." IN THIS SPECIFIC CASE, A LIMA DUAL MOBILITY LINER HAD BEEN COMBINED WITH A METAL HEAD FROM A DIFFERENT MANUFACTURER, WHICH IS A NOT ALLOWED COMBINATION. NEVERTHELESS, FURTHER ANALYSES WERE PERFORMED ON THE INVOLVED COMPONENTS: THE PRODUCTION DOCUMENTS OF THE LIMA MOBILE LINER WERE CHECKED, AND NO PRE-EXISTING DEVIATION WAS DETECTED ON THE COMPONENTS PLACED ON THE MARKET WITH THE SAME LOT. THUS, WE CAN STATE THAT THEY HAD BEEN MANUFACTURED UP TO DRAWINGS SPECIFICATIONS, A DIMENSIONAL CHECK WAS PERFORMED ON THE ONLY LIMA COMPONENT RETURNED (THE POLYETHYLENE LINER), A SLIGHT DEVIATION FROM THE TOLERANCES WAS FOUND. TAKING INTO ACCOUNT THAT THE COMPONENT IS MADE OF POLYETHYLENE, THIS DEVIATION IS MOST PROBABLY RELATED TO THE IN VIVO USE OF THE COMPONENT. THIS STATEMENT IS ALSO SUPPORTED BY THE ABSENCE OF DEVIATIONS DETECTED BY THE CHECK OF THE PRODUCTION DOCUMENTS, AS THE FEMORAL HEAD IS NOT A LIMA DEVICE, WE CANNOT PERFORM ANY SPECIFIC ANALYSIS ON IT. IN CONCLUSION, BASED ON THE ANALYSES PERFORMED, THE CAUSE OF THE DISASSEMBLY BETWEEN THE HEAD AND THE DUAL MOBILITY LINER REPORTED, IS RELATED TO THE USE OF A NOT ALLOWED COMPONENTS COMBINATION. EVENT NOT PRODUCT-RELATED. PMS DATA: BASED ON LIMACORPORATE PMS DATA, WE CAN ESTEEM A REVISION RATE DUE TO DISASSEMBLY OF THE FEMORAL HEADS FROM THE MOBILE LINER FOR 28 MM HEADS WITH CODES 5566.50.401÷580 OF 0,038%. NONE OF THE SIMILAR CASES WE COULD ALREADY INVESTIGATE WAS CLASSIFIED AS PRODUCT-RELATED.

Description of Event or Problem · 0

HIP REVISION SURGERY PERFORMED ON (B)(6) 2021 DUE TO LUXATION OF THE MOBILE LINER ØINT 28 MM Ø42 MM (PRODUCT CODE 5566.50.420, LOT #20AT020 - STER. 2000200). IT WAS REPORTED THAT THE FEMORAL HEAD (FROM A DIFFERENT MANUFACTURER) DISASSEMBLED FROM THE DUAL MOBILITY LINER. ACCORDING TO THE COMPLAINT SOURCE, NO TRAUMA OR INCIDENT WAS REPORTED BY THE PATIENT. THE COMPLAINT SOURCE INFORMED US THAT THE PREVIOUS SURGERY WAS A REVISION SURGERY DUE TO SIMILAR CAUSES (CODES AND LOT# OF THE INVOLVED DEVICES ARE NOT KNOWN) AND TOOK PLACE ON (B)(6) 2021. DURING THE PREVIOUS SURGERY THE INVOLVED MOBILE LINER (PRODUCT CODE 5566.50.420, LOT #20AT020) AND THE LINER FOR DUAL MOBILITY (PRODUCT CODE 5885.09.042, LOT 2012303) HAD BEEN IMPLANTED IN COMBINATION WITH STEM AND HEAD FROM A DIFFERENT MANUFACTURER. EVENT OCCURRED IN EUROPE.

Additional Manufacturer Narrative · 1

BY CHECKING THE DHR OF THE LOT #20AT020, NO PRE-EXISTING ANOMALIES WERE DETECTED ON THE MOBILE LINERS MANUFACTURED WITH THE SAME LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT#. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

Description of Event or Problem · 1

HIP REVISION SURGERY PERFORMED ON (B)(6) 2021 DUE TO LUXATION OF THE MOBILE LINER ØINT 28 MM Ø42 MM (PRODUCT CODE 5566.50.420, LOT #20AT020 - STER. 2000200). IT WAS REPORTED THAT THE FEMORAL HEAD (FROM A DIFFERENT MANUFACTURER) DISASSEMBLED FROM THE DUAL MOBILITY LINER. ACCORDING TO THE COMPLAINT SOURCE, NO TRAUMA OR INCIDENT WAS REPORTED BY THE PATIENT. ACCORDING TO THE INFORMATION RECEIVED, THE PREVIOUS SURGERY WAS A REVISION SURGERY DUE TO SIMILAR CAUSES (CODES AND LOT# OF THE INVOLVED DEVICES ARE NOT KNOWN) AND TOOK PLACE ON (B)(6) 2021. DURING THE PREVIOUS SURGERY THE INVOLVED MOBILE LINER (PRODUCT CODE 5566.50.420, LOT #20AT020) AND THE LINER FOR DUAL MOBILITY (PRODUCT CODE 5885.09.042, LOT 2012303) HAD BEEN IMPLANTED IN COMBINATION WITH STEM AND HEAD FROM A DIFFERENT MANUFACTURER. EVENT HAPPENED IN (B)(6).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
576019	MOBILE LINER INT 28 MM 42 MM	MOBILE LINER DIA.INT.28MM DIA.EXT.42MM	LZO	LIMACORPORATE SPA	5566.50.420	20AT020

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention