MAUDE Adverse Event Report: LIMACORPORATE S.P.A : SMR REVERSE LINER RETENTIVE

Model Number 1365.50.821

Device Problems Material Separation (1562); Device Dislodged or Dislocated (2923); Output Problem (3005)

Patient Problems Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/28/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturing records were checked confirming the batch number involved was manufactured correctly up to specification and in-line with the relevant checks and tests.No manufacturing deviations were reported.We will evaluate the additional info provided by the complaint source, sending a final investigation report as soon as the investigation will be completed.

Event Description

Smr reverse revision surgery performed on (b)(6) 2022 due to smr reverse liner dissociation from metal back glenoid.Component explanted: smr reverse liner retentive, product code 1365.50.821, lot #21at0fb, ster.2100270.Event happened in the us.

Manufacturer Narrative

Investigation manufacturing records were checked confirming the batch number involved was manufactured correctly up to specification and in-line with the relevant checks and tests.No manufacturing deviations were reported.X-ray analysis three shoulder x-rays were provided, 1= date of (b)(6) 2022(post operative after initial surgery date of (b)(6) 2021) 1= date of (b)(6) 2022(post operative after revision surgery date of (b)(6) 2022) 1= date unknown.The x-rays along with complaint details were evaluated by a medical consultant.The consultant's response was the following."the radiographs from (b)(6) 2022 show an incomplete connection of the glenosphere to the metal back at the conus connection, a slight malalignment of the central axis of the glenosphere in regard to the peg and baseplate can be observed.This is due to incomplete seating during surgery.This is a surgical error and not an implant related issue.After the revision the radiograph looks unremarkable.The last radiograph in the ppt-presentation (date?) shows a partially subluxated humeral component, which is not normal anyway." based on the few information received, we are not able to further investigate the root cause of the event.Considering that: check of the manufacturing charts highlighted no anomalies on components manufactured with the involved lot #21at0fb.The medical consultant's evaluation that "this is a surgical error and not an implant related issue." we can state that the event was not product related.Pms data according to limacorporate pms data, revision rate of smr reverse prosthesis due to disassociation is 0.009%.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 issues.Note - this is final mdr.

Event Description

Smr reverse revision surgery performed on (b)(6) 2022 due to smr reverse liner dissociation from metal back glenoid.Component explanted: smr reverse liner retentive, product code 1365.50.821, lot #21at0fb, ster.2100270.Previous surgery date - (b)(6) 2021.Patient - female.Age - 78yrs old.Approx.Weight - 1.57m.Approx.Weight - 52.16 kg.Event happened in us.

• Brand Name: : SMR REVERSE LINER RETENTIVE
• Type of Device: : SMR REVERSE LINER RETENTIVE
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale, 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale, 52; villanova di san daniele, udine 33038
• MDR Report Key: 14303758
• MDR Text Key: 290927297
• Report Number: 3008021110-2022-00030
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K142139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1365.50.821
• Device Lot Number: 21AT0FB
• Is the Reporter a Health Professional?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 52 KG