MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.15MM

Model Number 1304.15.150

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 03/28/2022

Event Type  Injury  

Manufacturer Narrative

Checking the sterilization charts of the involved lot #s, no anomalies were found on the items manufactured with the involved lot #s.This is the first and only complaint received on these lot #s/ster.We will submit a final mdr as soon as the investigation will be completed.

Event Description

Shoulder revision surgery performed on (b)(6) 2022, due to infection.The following components were removed and replaced: smr cementless finned stem (product code 1304.15.150, lot #2119081, ster.2100290); smr reverse humeral body (product code 1352.20.010, lot #2125437, ster.2200016); product not sold in the us.Smr reverse hp liner short (product code 1365.09.010, lot #2122898, ster.2100350); product not sold in the us.Smr connector small r - screw (product code 1374.15.305, lot #2201508, ster.2200030) it was reported that swabs were taken for analysis.Previous surgery took place on (b)(6) 2022.Patient is a female, (b)(6) years old.Event happened in (b)(6).

Manufacturer Narrative

Checking the sterilization charts of the involved lot #s, no pre-existing anomaly was found.Therefore, all the products with these lot #s have been properly 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: x-rays pre-operative or post-operative of the revision surgery; pathogen responsible for the infection.Based on the very few information received, we are not able to further investigate the root cause of the event.However, considering that the check of the sterilization charts highlighted no anomalies on the total number of components manufactured with the involved lot #s, we can state that the event was not product related.Pms data.According to limacorporate pms data, revision rate of smr reverse due to infection is 0.069%.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 final mdr.

Event Description

Shoulder revision surgery of a smr reverse prosthesis performed on (b)(6) 2022, due to infection.The following components were removed and replaced: smr cementless finned stem (product code 1304.15.150, lot #2119081 - ster.2100290) smr reverse humeral body (product code 1352.20.010, lot #2125437 - ster.2200016) - product not sold in the us.Smr reverse hp liner short (product code 1365.09.010, lot #2122898 - ster.2100350) - prduct not sold in the us.Smr connector small r - screw (product code 1374.15.305, lot #2201508 - ster.2200030).It was reported that swabs were taken for analysis, however the results are not known.Previous surgery took place on (b)(6) 2022.Patient is a female, 68 years old.Event happened in australia.

• Brand Name: SMR CEMENTLESS FINNED STEM
• Type of Device: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.15MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 14049911
• MDR Text Key: 288853090
• Report Number: 3008021110-2022-00024
• 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,Followup
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1304.15.150
• Device Lot Number: 2119081
• Is the Reporter a Health Professional?: No
• 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