MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CEMENTLESS FINNED STEM 2; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.23MM

Model Number 1304.15.230

Device Problem Packaging Problem (3007)

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

Event Date 10/10/2022

Event Type  malfunction  

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly was detected on the (b)(4) stems that belong to lot number 1814093.This is the first and only complaint received on this lot number.We will submit a final report as soon as the investigation will be completed.

Event Description

Intra-operative issue occurred during shoulder surgery: the package of the smr cementless finned stem, product code 1304.15.230, lot 1814093, ster.1800338 was found broken.The issue caused a prolongation of the surgical time of about 5 minutes, the next size of stem was used to complete the surgery.Event occurred in (b)(6).

• Brand Name: SMR CEMENTLESS FINNED STEM 2
• Type of Device: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.23MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via naizonale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 15673925
• MDR Text Key: 307169033
• Report Number: 3008021110-2022-00107
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1304.15.230
• Device Lot Number: 1814093
• 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): Hospitalization