MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR REVERSE LINER RETENTIVE; REVERSE RETENTIVE LINER 40MM +6MM

Model Number 1365.50.821

Device Problem Material Separation (1562)

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

Event Date 04/22/2022

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 send a final mdr once the investigation will be completed.

Event Description

Smr reverse revision surgery performed on april 22nd, 2022 due to disassociation of smr reverse liner - product code 1365.50.821, lot 21at0fb, ster 2100270 from 140° reverse humeral body.Previous surgery took place on (b)(6) 2022.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.According to the labelling of smr reverse humeral body 140°, for this component the coupling is only allowed with liners belonging to the codes 1360.50.0xx, 1361.50.0xx, 1360.50.8xx, 1361.50.8xx.Therefore, the coupling with a reverse liner with product code 1365.50.821 should be considered an off-label use.Explants and x-rays analysis: the explants are not available for further investigation.However, the complaint source shared the relevant x-rays, that have been sent to the medical expert for evaluation.Based on his opinion, "loosening of a liner almost always is a surgical error by not engaging the conical taper correctly.When there it is hard to prove afterwards, the aforementioned facts give some idea that a surgical error is the most likely reason for this early revision.I cannot see an implant-related problem here." therefore, considering that: - no anomalies have been found by checking the manufacturing charts of the involved component.- according to the medical expert's evaluation, a surgical error is the most likely reason for this revision and there is no evidence of implant-related concerns.We can conclude that the issue is not product related.Pms data: according to the pms data, the occurrence rate of dislocation for the smr reverse liners belonging to the product family codes 1360.50.Xxx, 1361.50.Xxx and 1365.50.Xxx is around 0,020%.No corrective actions are required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.

Event Description

Smr reverse revision surgery performed on (b)(6) 2022 due to disassociation of smr reverse liner - product code 1365.50.821, lot 21at0fb, ster (b)(6) from 140° reverse humeral body.Previous surgery took place on (b)(6), 2022.Event happened in united states.

• Brand Name: SMR REVERSE LINER RETENTIVE
• Type of Device: REVERSE RETENTIVE LINER 40MM +6MM
• 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: 14425887
• MDR Text Key: 291946055
• Report Number: 3008021110-2022-00039
• 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: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/20/2023
• 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): Required Intervention