MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR GLENOSPHERE DIA.36MM; GLENOSPHERE DIA. 36 MM

Model Number 1374.09.111

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2021

Event Type  malfunction  

Event Description

Intra-op issue experienced on (b)(6) 2021 during a shoulder conversion: surgeon could not separate the smr connector - product code 1374.15.322, lot 2000209 - from the smr glenosphere dia.36mm - product code 1374.11.100, lot 2108800, ster 2100218 when attempting to replace the connector size.According to the complaint source, after trying to disengage the two components for several minutes by using the correct instruments and following all the steps as per surgical technique, surgeon decided to conclude the surgery by implanting new components of the same size.Patient is male, 50 years old.Event happened in us.

Manufacturer Narrative

By checking the manufacturing charts of the involved lot#, no pre-existing anomaly was found on a total of 7 glenospheres manufactured with the same lot#.No other complaints received on the same lot#.We will send a final incident report once the investigation will be completed.

Event Description

Intra-operative issue experienced on 14th of december 2021 during a shoulder conversion: surgeon could not separate the smr connector - product code 1374.15.322, lot 2000209 - from the smr glenosphere dia.36mm - product code 1374.09.111, lot 2108800, sterilization 2100218 when attempting to replace the connector size.According to the complaint source, after trying to disengage the two components for several minutes by using the correct instruments and following all the steps as per surgical technique, surgeon decided to conclude the surgery by implanting the following new components: - smr glenosphere dia.36mm - product code 1374.09.111, lot 2108927, sterilization 2100234.- smr connector - product code 1374.15.312, lot 2005273, sterilization 2000200.Patient is male, 50 years old.Event happened in united states.

Manufacturer Narrative

Explants analysis the pieces involved in the complaint have been returned to limacorporate for further investigation.Firstly, the pieces have been separated and then they have been measured, to detect any dimensional anomalies.The hole has been found slightly deformed, probably due to the attempts to disengage the two components.Then the pieces underwent a functional test, following the steps on the surgical technique.Based on the information received from the complaint source, the surgeon could not separate the smr connector from the smr glenosphere when attempting to replace the connector size.According to the surgical technique, in order to proceed with the removal of the glenosphere implant, the safety screw inside the glenosphere should be removed firstly, by using the appropriate screwdriver.Then the glenosphere extractor should be screwed on the previously implanted glenosphere, and the glenosphere should be disassembled from the metal back using the straight-handle (product code 9095.11.253).Therefore, following the surgical technique, an instrument that removes the glenosphere only, without removing the connector, is not available.By using the instruments available, it is only possible to remove both the glenosphere and the connector (because the instrument engages the connector through the glenosphere).In conclusion: - checking the manufacturing chart, no pre-existing anomaly has been discovered - the dimensional check highlighted a slight deformation of the hole, probably due to the multiple attempts to disengage the components - according to the surgical technique, the glenosphere and the connector can only be removed together therefore, we can state that the event is not product related.Pms data according to limacorporate pms data, the occurrence rate of this kind of event that involved the smr glenospheres, belonging to the family product codes 1374.09.Xxx/1376.09.Xxx/1374.15.Xxx/1376.15.Xxx is around 0.01%.Based on the investigation performed, no corrective actions are required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.

• Brand Name: SMR GLENOSPHERE DIA.36MM
• Type of Device: GLENOSPHERE DIA. 36 MM
• 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: 14712481
• MDR Text Key: 301820735
• Report Number: 3008021110-2022-00051
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K163397
• 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: 04/30/2024

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 Model Number: 1374.09.111
• Device Lot Number: 2108800
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2024
• 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): Other