MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR - GLENOSPHERE IMPACTOR-EXTRACTOR

Model Number 9013.74.141

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

By checking the dhr of the involved lot #, no pre-existing anomaly was found on the items placed on the market with the same lot #.We will submit a final mdr once the investigation will be completed.

Event Description

During shoulder revision surgery performed on (b)(6) 2021, the push rod of the smr - glenosphere impactor-extractor (product code 9013.74.141, lot #16ab059) became stuck in the baseplate.According to the reported information, after reducing the shoulder, it was determined to re-orient the lateralized 40 glenosphere definitive implant.The push rod and glenosphere impactor/extractor were threaded into the glenosphere to break the taper and re-orient the component.According to the complaint source, resistance was met, and there was no popping sound.While trying to remove the glenosphere impactor/extractor, the push rod remained in the baseplate while the impactor/extractor was unthreaded from the glenosphere.After multiple attempts using an ostetome, the glenosphere was removed from the baseplate.However, the push rod remained in the baseplate, and it was not possible to remove it after multiple attempts.The baseplate was explanted.A new tt baseplate and a medium tt peg were implanted.A +4 lateralized 40 concentric glenosphere and a standard 40 retentive liner were implanted.Surgery prolonged of 15 minutes.According to the complaint source, the instrument was handled appropriately, and the surgical technique was followed correctly.The revision surgery was registered as complaint (b)(4) and it was due to dislocation.Event happened in the us.

• Brand Name: SMR - GLENOSPHERE IMPACTOR-EXTRACTOR
• Type of Device: GLENOSPHERE IMPACTOR-EXTRACTOR
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazinale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 12370028
• MDR Text Key: 283150604
• Report Number: 3008021110-2021-00069
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K110598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial

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: No Information
• Device Model Number: 9013.74.141
• Device Lot Number: 16AB059
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other