MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.21MM

Model Number 1304.15.210

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Bacterial Infection (1735)

Event Date 06/29/2022

Event Type  Injury  

Event Description

Shoulder revision surgery of a smr reverse prosthesis performed on (b)(6) 2022 due to infection and loosening.It was reported that the pathogen responsible for the infection is streptococcus.All components have been removed: smr cementless finned stem (product code 1304.15.210, lot #1402657 - ster.2000042).Smr reverse finned humeral body (product code 1352.15.050, lot #2117892 - ster.2100292).Smr reverse hp lateralizing liner medium (product code 1362.09.115, lot #2123407 - ster.2200002) - product not sold in the us.Smr connector small std (product code 1374.15.310, lot #2025211 - ster.2100084).Smr reverse hp glenosphere 44 mm (product code 1374.50.440, lot #2123531 - ster.2100332) - product not sold in the us.Smr uncemented glenoid # small (product code 1375.20.020, lot #2118664 - ster.2100316) - product not sold in the us.Bone screw ø6,5 h.25mm (product code 8420.15.020, lot #2122801 - ster.2100340).Bone screw ø6,5 h.35mm (product code 8420.15.040, lot #2016866 - ster.2000322) a cement spacer was inserted.Previous surgery took place on (b)(6) 2022.Patient is a male.It was reported that patient has high bmi and performs low activity level.According to the complaint source he's a smoker and unhealthy with comorbidities.Event happened in australia.

Manufacturer Narrative

Checking the sterilization charts of the involved lot #s, no pre-existing anomaly was found on the components processed with those sterilization #s.Therefore, all the products with those lot #s have been properly sterilized before being placed on the market.No additional details were available on this post-operative issue, specifically pre-operative and post-operative x-rays of the revision surgery were requested to the complaint source, however they were not available.Based on the very few information received, we are not able to further investigate the root cause of the event.However, considering that check of the sterilization charts highlighted no anomalies on the components sterilized by the involved sterilization numbers, 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 0.070%.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 issue.Note: this is a combined initial-final mdr.

• Brand Name: SMR CEMENTLESS FINNED STEM
• Type of Device: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.21MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 14944098
• MDR Text Key: 295407764
• Report Number: 3008021110-2022-00062
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K101263
• 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: 07/07/2022

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: 1304.15.210
• Device Lot Number: 1402657
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/07/2022
• 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