LINER #L FOR MOBILE LINER Ø42
Report
- Report Number
- 3008021110-2022-00009
- Event Type
- Injury
- Date Received
- February 15, 2022
- Date of Event
- January 10, 2022
- Report Date
- September 27, 2023
- Manufacturer
- LIMACORPORATE S.P.A.
- Product Code
- LZO
- PMA / PMN Number
- K181491
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
MANUFACTURING RECORDS WERE CHECKED CONFIRMING THE BATCH NUMBER INVOLVED (2115887) WAS MANUFACTURED CORRECTLY UP TO SPECIFICATION AND IN-LINE WITH THE RELEVANT CHECKS AND TESTS. NO MANUFACTURING DEVIATIONS WERE REPORTED. NO OTHER COMPLAINTS RECEIVED ON A TOTAL OF 18 ITEMS MANUFACTURED WITH THE SAME LOT#. PLEASE NOTE THIS CASE (OPEN REDUCTION DUE TO DISLOCATION) WAS INITIALLY NOT CLASSIFIED BY THE COMPANY AS MEDICAL COMPLAINT. NEW EVALUATION OF THE CASE WAS PERFORMED AFTER INTERACTION WITH FDA DUE TO SURGEON'S REQUEST FOR A NEW COMPASSIONATE COMPONENT TO BE IMPLANTED DURING THE REVISION SURGERY THAT WILL BE PERFORMED ON (B)(6) 2022. WE WILL SEND A FINAL MDR ONCE THE REVISION SURGERY WILL BE PERFORMED.
CHECKING THE DEVICE HISTORY RECORDS OF THE INVOLVED LOT #19AR05E, NO PRE-EXISTING ANOMALY WAS FOUND ON THE (B)(4) MANUFACTURED WITH THAT LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THE LOT #. FURTHER CHECKING THE MANUFACTURING CHARTS OF LOT #2221538, NO ANOMALY WAS FOUND ON THE(B)(4) MANUFACTURED WITH THAT LOT #. DEVICE ANALYSIS THE INSTRUMENT INVOLVED WAS RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. VISUAL INSPECTION FOUND THAT THE THREADED TIP OF THE INSTRUMENT IS SEVERELY DAMAGED . IT IS VISIBLE THAT ONE OF THE THREADS HAD BROKEN AND PARTIALLY DETACHED. IT IS THEREFORE SUPPOSED THAT THE DEFINITIVE CUP WAS SCREWED IN CROOKED IN RESPECT TO THE INSTRUMENT'S VERTICAL AXIS, SO THAT IT CAUSED AN ABNORMAL LOAD ON THE THREAD CAUSING ITS PARTIAL DETACHMENT. ACCORDING TO THE SURGICAL TECHNIQUE, FOLLOWING THE ACETABULAR REAMING PROCEDURE, THE TRIAL CUP IS THREADED ONTO THE BEATER-POSITIONER-ALIGNER (PRODUCT CODE 9057.20.555) OR ONTO THE MULTI-PURPOSE HANDLE (PRODUCT CODE (9055.28.400) FOR VISUALIZATION AND ASSESSMENT OF FIT, CONTACT, CONGRUENCY AND ORIENTATION WITHIN THE ACETABULUM. THEN, THE DEFINITIVE CUP WITH THE SAME NOMINAL DIAMETER OF THE FINAL TRIAL CUP USED IS IMPACTED IN THE ACETABULUM. THE DEFINITIVE IMPLANT IS PLACED ONTO THE CUP ADAPTOR (SIZE DEPENDS ON CUP'S SIZE) AND TO THE WRENCH FOR DELTA CUPS (PRODUCT CODE 9055.51.015). THE DEFINITIVE CUP IS SO IMPACTED. HOWEVER, ACCORDING TO THE RECEIVED INFORMATION, THE INSTRUMENT GOT DAMAGED DURING THE SURGERY WHEN IT WAS USED TO IMPACT THE DEFINITIVE ACETABULAR CUP (BELONGING TO LOT #2221538), THEREFORE THE INSTRUMENT HAD BEEN USED OFF-LABEL. CONSIDERING THAT: · CHECK OF THE DEVICE HISTORY RECORDS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH LOT #19AR05E; · THE DAMAGE OBSERVED SUGGESTED THAT THE CUP WAS SCREWED CROOKED IN RESPECT TO THE VERTICAL AXIS OF THE INSTRUMENT; · ACCORDING TO THE RECEIVED INFORMATION, THE INSTRUMENT HAD BEEN USED OFF-LABEL. INDEED, IT WAS USED TO IMPACT THE DEFINITIVE CUP, WHEREAS THE INSTRUMENT IS INTENDED TO BE USED WITH TRIAL CUPS ONLY; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. IT IS HYPOTHESIZED THAT THE DEFINITIVE CUP WAS NOT PROPERLY SCREWED ON THE INSTRUMENTS THREAD, THEREFORE THE EVENT CAN BE CLASSIFIED AS USER RELATED. PMS DATA ACCORDING TO OUR PMS DATA, WE CAN ESTIMATE THE BREAKAGE RATE OF THE THREAD OF THE INSTRUMENT 9057.20.555 TO BE (B)(4). 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. LIMACORPORATE CONTINUES MONITORING COMPLAINTS AS PER INTERNAL POST MARKET SURVEILLANCE PROCEDURES AND FURTHER CORRECTIVE/PREVENTIVE ACTIONS ARE RE-EVALUATED IN THE EVENT OF UNEXPECTED INCREASES OF THE OCCURRENCE RATE. NOTE: THIS IS A FINAL MDR.
INVESTIGATION. MANUFACTURING RECORDS WERE CHECKED CONFIRMING THE BATCH NUMBER INVOLVED (2115887) WAS MANUFACTURED CORRECTLY UP TO SPECIFICATION AND IN-LINE WITH THE RELEVANT CHECKS AND TESTS. NO MANUFACTURING DEVIATIONS WERE REPORTED. NO OTHER COMPLAINTS RECEIVED ON A TOTAL OF (B)(4) ITEMS MANUFACTURED WITH THE SAME LOT NUMBER. PLEASE NOTE THIS CASE (CLOSED REDUCTION DUE TO DISLOCATION) WAS INITIALLY NOT CLASSIFIED BY THE COMPANY AS MEDICAL COMPLAINT. NEW EVALUATION OF THE CASE WAS PERFORMED AFTER INTERACTION WITH FDA DUE TO SURGEON'S REQUEST FOR A NEW COMPASSIONATE COMPONENT IMPLANTED DURING THE REVISION SURGERY THAT HAS BEEN PERFORMED ON (B)(6) 2022. EXPLANTS AND X-RAYS ANALYSIS. THE COMPONENTS WERE NOT AVAILABLE FOR ANALYSIS. HOWEVER, WE HAVE RECEIVED THE X-RAYS TAKEN BEFORE AND AFTER THE SURGERY OBJECT OF THIS REPORT, AND THEY HAVE BEEN SENT TO THE MEDICAL EXPERT. HE COMPLETED HIS ASSESSMENT WITH THE FOLLOWING SENTENCE: "THE CASE IS ANYTHING ELSE BUT A SIMPLE ONE. I BELIEVE IT COULD HAVE BEEN TREATED MORE SUFFICIENTLY DURING ALL THE STEPS DESCRIBED. NONETHELESS IT IS NOT THE FAULT OF THE IMPLANTS BUT CONSEQUENCE OF SUBOPTIMAL SURGERY AND/OR CHOICE OF IMPLANTS.". IN CONCLUSION, CONSIDERING THAT: 1) MANUFACTURING RECORDS WERE CHECKED CONFIRMING THE BATCH NUMBER INVOLVED (2115887) WAS MANUFACTURED CORRECTLY UP TO SPECIFICATION AND IN-LINE WITH THE RELEVANT CHECKS AND TESTS. 2) THE MEDICAL EXPERT DID NOT SEE ANY FAULT OF THE IMPLANT BY ANALYZING THE X-RAYS RECEIVED. WE CAN SUPPOSE THAT THE ISSUE WAS NOT PRODUCT RELATED. PMS DATA. ACCORDING TO THE PMS DATA, THE OCCURRENCE RATE OF DISLOCATION FOR THE MOBILE LINERS BELONGING TO THE PRODUCT FAMILY CODES 5885.09.040 AND 5885.09.042 IS AROUND (B)(4). NO CORRECTIVE ACTIONS ARE REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. THIS IS A FINAL MDR.
OPEN REDUCTION DUE TO HIP DISLOCATION PERFORMED ON (B)(6) 2022. PATIENT CLINICAL HISTORY: · PATIENT, A (B)(6) FEMALE, UNDERWENT SUCCESSFUL PROMADE (CMD 21-1247) SURGERY ON (B)(6) 2021 AFTER A LONG HISTORY OF HIP PROBLEMS (FAILED RIGHT TOTAL HIP REPLACEMENT WITH PELVIC DISCONTINUITY) · PATIENT DID NOT FOLLOW UP FOR 6 WEEKS AND THEN RETURNED ON (B)(6) 2021 WITH DISLOCATED HIP AND DID NOT EVEN KNOW IT HAPPENED. THE SURGEON COULD NOT REDUCE THE HIP CLOSED AND THEN PROCEEDED WITH AN OPEN REDUCTION AND TIGHTENED N.4 OF THE N.8 SCREWS THAT WERE CONSIDERED MILDLY LOOSE. SURGEON WAS SATISFIED WITH RESULTS; · ON (B)(6) 2022, PATIENT RETURNED TO HOSPITAL WITH A DISLOCATION FROM LEANING FORWARD (POSITION UNKNOWN). SURGEON ASSOCIATED THE DISLOCATION WITH INSUFFICIENT SOFT TISSUE AND TRIED A CLOSED REDUCTION ON (B)(6) 2022 (OBJECT OF THIS REPORT) TO DEFINITELY FACE THE DISLOCATION EXPERIENCED, THE SURGEON HAS REQUESTED A CUSTOMIZED CONSTRAINED DUAL MOBILITY LINER PLANNING TO PERFORM THE REVISION SURGERY ON (B)(6) 2022. LIMA PRODUCT INVOLVED (STILL IN SITU): STD LINER #L FOR MOBILE LINER Ø42, PRODUCT CODE: 5885.09.042, LOT# 2115887, (B)(4).
DURING A HIP ARTHROPLASTY PERFORMED ON (B)(6), 2022, THE THREAD OF THE BEATER - POSITIONER - ALIGNER (PRODUCT CODE 9057.20.555, LOT #19AR05E) BROKE. IT WAS REPORTED THAT WHEN THE DELTA TT ACETABULAR CUP D.52MM (PRODUCT CODE 5552.15.520, LOT #2221538 - STER. 2200286) WAS INSERTED AND FLUSHED, THE BROKEN TIP OF THE IMPACTOR WAS NOTICED. IT WAS REPORTED THAT THE DEFINITIVE ACETABULAR CUP NEEDED TO BE REMOVED BECAUSE ITS ANGLE WAS NOT APPROPRIATE. THE CUP WAS AGAIN INSERTED, AND ACCORDING TO THE RECEIVED INFORMATION THE THREAD OF THE INSTRUMENT BROKE WHEN THE ACETABULAR CUP WAS REMOVED. NO RESIDUAL FRAGMENT WAS CONFIRMED ON THE PATIENT. ACCORDING TO THE RECEIVED INFORMATION, THE NUMBER OF USES OF THE INSTRUMENT IS NOT KNOWN. DUE TO THE ISSUE THE SURGICAL TIME GOT PROLONGED OF 2-3 MINUTES. SURGERY WAS SUCCESSFULLY COMPLETED USING ANOTHER INSTRUMENT. PATIENT IS A FEMALE. EVENT HAPPENED IN JAPAN.
CLOSED REDUCTION DUE TO HIP DISLOCATION PERFORMED ON (B)(6) 2022. PATIENT CLINICAL HISTORY: PATIENT, A 69 YEARS OLD FEMALE, UNDERWENT SUCCESSFUL PROMADE (CMD 21-1247) SURGERY ON (B)(6) 2021 AFTER A LONG HISTORY OF HIP PROBLEMS (FAILED RIGHT TOTAL HIP REPLACEMENT WITH PELVIC DISCONTINUITY). PATIENT DID NOT FOLLOW UP FOR 6 WEEKS AND THEN RETURNED ON (B)(6) 2021 WITH DISLOCATED HIP AND DID NOT EVEN KNOW IT HAPPENED. THE SURGEON COULD NOT REDUCE THE HIP CLOSED AND THEN PROCEEDED WITH AN OPEN REDUCTION AND TIGHTENED N.4 OF THE N.8 SCREWS THAT WERE CONSIDERED MILDLY LOOSE. SURGEON WAS SATISFIED WITH RESULTS. · ON (B)(6) 2022, PATIENT RETURNED TO HOSPITAL WITH A DISLOCATION: THE PROSTHESIS DISLOCATED WHEN THE PATIENT WAS SITTING IN A CHAIR WITH HER ABDUCTION BRACE AND REACHED FORWARD. SURGEON ASSOCIATED THE DISLOCATION WITH INSUFFICIENT SOFT TISSUE AND TRIED A CLOSED REDUCTION ON (B)(6) 2022 (OBJECT OF THIS REPORT). LIMACORPORATE PRODUCT INVOLVED: STD LINER #L FOR MOBILE LINER 42, PRODUCT CODE 5885.09.042, LOT NUMBER 2115887, STERILIZATION NUMBER 2100280. TO DEFINITIVELY FACE THE DISLOCATION EXPERIENCED, THE SURGEON HAS REQUESTED A CUSTOMIZED CONSTRAINED DUAL MOBILITY LINER AND THE REVISION SURGERY HAS BEEN PERFORMED ON (B)(6) 2022. SUBSEQUENTLY THE PATIENT UNDERWENT A FURTHER REVISION SURGERY ON (B)(6) 2022 DUE TO INFECTION, AND DURING THIS LAST SURGERY THE CUSTOMIZED DUAL MOBILITY LINER WAS EXPLANTED. THIS EVENT HAS BEEN REGISTERED WITH THE INTERNAL COMPLAINT 360/22 AND NOTIFIED TO THE FDA BY THE COMPASSIONATE USE REPORT U220060/R001. EVENT HAPPENED IN UNITED STATES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1777547 | LINER #L FOR MOBILE LINER Ø42 | LINER #L FOR MOBILE LINER DIA.42 | LZO | LIMACORPORATE S.P.A. | 5885.09.042 | 2115887 | |
| 2660508 | LINER #L FOR MOBILE LINER Ø42 | LINER #L FOR MOBILE LINER DIA.42 | LZO | LIMACORPORATE S.P.A. | 5885.09.042 | 2115887 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other| R |