MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR HUMERAL EXTENSION + 9 MM; HUMERAL EXTENSION +9MM

Model Number 1352.15.001

Device Problems Mechanical Problem (1384); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Loss of Range of Motion (2032)

Event Date 02/09/2021

Event Type  Injury  

Manufacturer Narrative

By checking the dhrs of the lot #1314793, #1313949, #1403910, and #1402190, no pre-existing anomalies were detected on the instruments manufactured with this lot #.By checking the sterilization charts of the involved products, no pre-existing anomalies were found, thus we can state that all the components had been regularly sterilized before being placed on the market.We will send a final mdr once the investigation will be completed.

Event Description

Shoulder revision surgery performed on (b)(6) 2021 due to patient experiencing a significant reduction in movement.The original plan for the revision was to alter the modularity in the prosthesis to facilitate a more functional movement pattern.When the liner was removed, there was sign of potential infection below it.The following components were explanted: smr humeral extension + 9 mm (product code 1352.15.001, lot# 1314793 - ster.(b)(4)); smr reverse liner + 6 mm (product code 1360.50.020, lot# 1313949 - ster.(b)(4)) - product not marketed in the us; smr connector small r (product code 1374.15.305, lot# 1403910 - ster.(b)(4)); smr eccentrical glenosphere ø 36mm (product code 1376.09.031, lot# 1402190 - ster.(b)(4)).All removed components were replaced with new implants of the same size.A spacer and a constrained 36mm liner were used for a greater stability and range of motion.Previous surgery took place on (b)(6) 2014.Event happened in (b)(6).

Event Description

Shoulder revision surgery of an smr reverse implant performed on (b)(6) 2021 due to a significant reduction in movement experienced by the patient.The original plan for the revision was to alter the modularity in the prosthesis to facilitate a more functional movement pattern.When the reverse liner was removed, there was sign of potential infection below it.The following components were explanted: smr humeral extension + 9 mm (product code 1352.15.001, lot# 1314793 - ster.1300365) smr reverse liner + 6 mm (product code 1360.50.020, lot# 1313949 - ster.1300319) - product not marketed in the us smr connector small r (product code 1374.15.305, lot# 1403910 - ster.1400107) smr eccentrical glenosphere ø 36mm (product code 1376.09.031, lot# 1402190 - ster.1400062).All removed components were replaced with new implants of the same size.A +9mm spacer and a constrained 36mm liner were used for a greater stability and range of motion.Additionally, greater tuberosity was moved and positioned more inferiorly.According to the received information, the possibility of infection was managed intraoperatively and with iv antibiotics postoperatively.Previous surgery took place on june 6th, 2014.Patient is a female.It was reported sha has a normal bmi and is moderately active.Event happened in australia.

Manufacturer Narrative

By checking the sterilization charts of the involved products, no pre-existing anomalies were found, thus we can state that all the components had been regularly sterilized before being placed on the market.No additional details were available on this post-operative issue, specifically the following information was requested to the complaint source, but it was not available: pre-operative x-rays related to the revision surgery; confirming whether infection was present.Based on the very few information received, we are not able to further investigate the root cause of the event.However, checking the sterilization charts, no anomalies were found for the products placed on the market, thus 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 infection is 0,06%.No corrective actions required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.

• Brand Name: SMR HUMERAL EXTENSION + 9 MM
• Type of Device: HUMERAL EXTENSION +9MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 11347365
• MDR Text Key: 241429071
• Report Number: 3008021110-2021-00012
• 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,Followup
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1352.15.001
• Device Lot Number: 1314793
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention