MAUDE Adverse Event Report: LIMACORPORATE SPA SMR HUMERAL HEAD Ø42 MM; SMR HUMERAL HEAD Ø42 MM (KWT, HSD)

Model Number 1322.09.420

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 12/03/2019

Event Type  Injury  

Manufacturer Narrative

By checking the manufacturing charts of the involved lot#, no anomaly was detected on a total of (b)(4) humeral heads manufactured with lot# 1813567.This is the first and only complaint received on this lot#.We will submit a final mdr once the investigation will be concluded.

Event Description

Revision surgery performed on (b)(6) 2019 due to implant dislocation.Primary surgery was performed on (b)(6) 2019.According to the information reported, this patient had a fracture a few years ago that was plated but then failed, hence anatomic smr was implanted.It was reported that at that time, tuberosities had not healed yet.When smr anatomic dislocated, there was nearly no bone between the head and the stem as the tuberosities had eroded and not healed around the anatomic trauma body.It was reported that the plan was to leave the well fixed stem in situ but it easily pulled out when fixed to the trial reverse body.Therefore, the surgeon decided to upsize to a 16mm stem.The surgeon noted that the 15mm was possibly undersized and had been rotating inside the humeral canal as the canal was almost smooth hence used cement around the prosthesis for torsional stability.Event occurred in (b)(6).

• Brand Name: SMR HUMERAL HEAD Ø42 MM
• Type of Device: SMR HUMERAL HEAD Ø42 MM (KWT, HSD)
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: federica malvaso ; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 9457205
• MDR Text Key: 170427546
• Report Number: 3008021110-2019-00146
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1322.09.420
• Device Lot Number: 1813567
• Date Manufacturer Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention