MAUDE Adverse Event Report: LIMACORPORATE SPA FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.14MM

Model Number 1304.15.140

Device Problems Device Dislodged or Dislocated (2923); Compatibility Problem (2960)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The check of the manufacturing chart did not show any anomaly on a total of 35 smr cementless stems dia.14mm manufactured with lot# 201800642.First and only complaint reported on this lot#.We will send a final emdr once the evaluation will be concluded.

Event Description

Shoulder revision surgery performed on (b)(6) 2018 due to implant dislocation occurred when the patient levered the body weight up by using elbow.According to the info reported, an old fracture mal union + obesity of the patient (bmi unknown) could have contributed to the event but the real root cause seems to be related to a suboptimal choice of the stem size (heavily undersized) during the primary surgery performed on (b)(6) 2018.During the revision surgery, the smr cementless stem dia.14mm originally implanted was replaced by a cementless stem dia.17mm.Surgeon satisfied with final stability.Event occurred in (b)(6).

• Brand Name: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.14MM
• Type of Device: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.14MM
• Manufacturer (Section D): LIMACORPORATE SPA
• Manufacturer Contact: giulio puppa ; IT
• MDR Report Key: 7680763
• MDR Text Key: 113741864
• Report Number: 3008021110-2018-00055
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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

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 Operator: Health Professional
• Device Model Number: 1304.15.140
• Device Lot Number: 201800642
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: 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