MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR REVERSE LINER RETENTIVE; SMR SHOULDER SYSTEM - REVERSE RETENTIVE LINER 40MM +3MM

Model Number 1365.50.816

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 12/15/2022

Event Type  Injury  

Manufacturer Narrative

Investigation: by the check of the dhr, no anomalies on a total of n.34 smr reverse liner retentive manufactured with the same lot number (21at0f6).No other complaints have been received on the same lot number.According to the complaint source, no x-rays nor explanted component are available for further analysis.Considering its design features, the retentive liner allows the glenosphere to keep its original position, thanks to the higher edges.Therefore, this kind of liner could reduce the probability of dislocation of the glenosphere.Based on the very few information received, we are not able to further investigate the root cause of the event.However, considering the facts: · by the check of the dhr, no anomalies on a total of n.34 smr reverse liner retentive manufactured with the same lot number (21at0f6).We can conclude that the event was not product related.Pms analysis: according to limacorporate pms data, revision rate of smr reverse liner belonging to the codes 1360.50.Xxx, 1361.50.Xxx, 1365.50.Xxx for instability and implant dislocation is around 0.06%.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 a combined initial final mdr.

Event Description

Smr reverse revision surgery performed on (b)(6) 2022, due to instability.According to the complaint source, the smr reverse liner retentive + 3mm (product code 1365.50.816, lot number 21at0f6, sterilization 2100379) originally implanted on (b)(6) 2022, was replaced with a smr reverse liner retentive standard on (b)(6) 2022, due to dislocation.Surgeon was satisfied with the final outcome of the implant.The patient is a male, date of birth (b)(6) 1954.Event happened in united states.

• Brand Name: SMR REVERSE LINER RETENTIVE
• Type of Device: SMR SHOULDER SYSTEM - REVERSE RETENTIVE LINER 40MM +3MM
• 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: 18883721
• MDR Text Key: 337412381
• Report Number: 3008021110-2022-00140
• 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
• Report Date: 03/11/2024

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: 1365.50.816
• Device Lot Number: 21AT0F6
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2024
• 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