MAUDE Adverse Event Report: LIMACORPORATE SPA LINER #M FOR MOB. LINER 40; LINER #M FOR MOB. LINER Ø40

Model Number 5885.09.040

Device Problem Failure to Disconnect (2541)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturing charts of the liner with code 588509040, lot 1902828 were checked without finding any pre-existing anomaly that could have led to the reported issue.The dhr of the spacer (code 588615520, lot 1819812) was also checked and no pre-existing anomaly was detected.We will submit the final report after the conclusion of the investigation.

Event Description

Intra-operative issue experienced during hip surgery on (b)(6) 2020: the liner with code 5885.09.040 and lot# 1902828 did not disengage from the spacer housing (code 5886.15.520, lot#1819812).As a consequence, all the following components were explanted: delta-one-tt acetab.Cup ø54mm code 554914541 lot 2002092.Mobile liner øint 28 mm ø40 mm code 556650401 lot 18at2yx.Liner #m for mob.Liner ø40 code 588509040 lot 1902828.Delta angled spacer 20°# l+5 code 588615520 lot 1819812.Due to this issue, the surgery time was prolonged and boneloss of the acetabulum was also reported.Event occurred in (b)(6).

Manufacturer Narrative

The manufacturing charts of the liner with code 5885.09.040, lot 1902828 were checked without finding any pre-existing anomaly that could have led to the reported issue.The dhr of the spacer (code 588615520, lot 1819812) was also checked and no pre-existing anomaly was detected.This is the first and only complaint received on these lot#s.The explanted components were not available to be returned to lima corporate for analysis (discarded by the hospital), thus nor functional nor dimensional analyses can be performed on them.Without the possibility to analyze the components, we cannot go back with certainty to the root cause of the difficulties experienced by the surgeon in removing the metal liner.However, the surgical technique of the delta system clearly states that " if the metal liner becomes jammed sideways it will have to be removed by striking the metal rim of the cup with a flat bladed osteotome.The vibration will shake the liner out of the housing." the vibration can in fact help to disengage the components, which stability is guaranteed by the conical coupling between them.According to the information received, the liner extraction was attempted by using one of the following instruments, together with the ceramic liner positioner 9058.85.090 (it is unknown which one exactly): multi purpose handle 9055.32.025 lot #1107844 or lot #1111080.Joint for ceramic liner positioner 9058.85.110 lot #1109832 or lot #1106223.It should be taken into consideration that, if the liner extraction is not performed with an axial direction, it may occur that the liner moves to a slightly oblique position and consequently gets stuck inside the housing.No further analysis is possibile on this event, however, at this stage and based on the abovedescribed evaluation, this incident cannot be classified as product related.Pms data: based on our pms data, this is the only similar incident lima corporate is aware of (impossibility/difficulties to disengage the liner for double mobility - codes 5885.09.040/042), occurrence rate is lower than 0,01%.No corrective actions needed for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar event.

Event Description

Intra-operative issue experienced during hip revision surgery on (b)(6) 2020: the liner for double mobility with code 5885.09.040 and lot# 1902828 did not disengage from the spacer (code 5886.15.520, lot#1819812).As a consequence, the acetabular components had to be removed as a whole construct (acetabular cup, screw, spacer and liner), causing more boneloss in the acetabulum than expected.The previous surgery was performed on (b)(6) 2020.The details of the other components removed on (b)(6) 2020 are the following: delta-one-tt acetab.Cup ø54mm code 554914541 lot 2002092 mobile liner øint 28 mm ø40 mm code 556650401 lot 18at2yx liner #m for mob.Liner ø40 code 588509040 lot 1902828 delta angled spacer 20°# l+5 code 588615520 lot 1819812 due to this intra-operative issue, the surgery time was prolonged, but is unknown of how many minutes.According to the information received, the incident occurred during a revision surgery due to acetabular bone fracture caused by patient's poor bone quality and trauma.The complaint source reported that the bone fracture had caused cup (and screw) protrusion into pelvic, in proximity to blood vessels, thus it would have been preferable to remove each component separately instead of as a whole construct.The revision surgery was registered as complaint #358/20, but not reported to the competent authority as due to patient's condition only.It seems that the previous surgery (on (b)(6) 2020) was also a revision surgery, caused by acetabular cup loosening, but no further details are available thus the event was not registered due to lack of minimum information.Patient data: female, age 76.Bmi 42.Independent living, walking with one stick.Event occurred in (b)(6).

• Brand Name: LINER #M FOR MOB. LINER 40
• Type of Device: LINER #M FOR MOB. LINER Ø40
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 11036185
• MDR Text Key: 251614421
• Report Number: 3008021110-2020-00111
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K181491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5885.09.040
• Device Catalogue Number: 5885.09.040
• Device Lot Number: 1902828
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization