MAUDE Adverse Event Report: LIMACORPORATE SPA SMR FINNED HUMERAL STEMS - 60MM (TI6AL4V) DIA.12MM; HSD-KWT

Model Number 1304.15.120

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Sterilization charts of the explanted devices (mini stem, reverse humeral body, reverse liner, glenosphere, glenosphere connector + screw, metal back glenoid) were checked; all the devices were regularly sterilized before being placed on the market.No other complaints reported on the lot # of the devices involved.We will submit a final mdr once the investigation will be completed.

Event Description

Smr reverse total shoulder arthroplasty was implanted on (b)(6) 2016.Revision surgery was done after less than one month from the primary surgery due to infection.All the components were removed and a course of antibiotics was administered to the patient.Event happened in (b)(6).

Manufacturer Narrative

Sterilization charts of the explanted devices (mini stem, reverse humeral body, reverse liner, glenosphere, glenosphere connector + screw, metal back glenoid) were checked; all the devices were regularly sterilized before being placed on the market.We did not receive the explanted items, but we received the available x-rays and we asked a medical expert to evaluate them.We report below his analysis.The surgeon probably experienced some difficulties during the previous surgery, because a small stem was used and the reverse humeral body was placed too high.Moreover, from the x-rays it seems that there was an old humeral fracture.If the surgeon experienced some difficulties, it could mean that the surgery time got extended and that the tissue was exposed for a long period, thus predisposing to an infection.There might be possible patient factors as well which we are not aware of.The fact that the symptoms of pain and swelling occurred so soon after the previous surgery implies that the infection likely occurred at the time of operation.We asked to the complaint source if any samples were collected and tested at the time of revision.According to the received information, although at the time of revision surgery, the patient presented with signs of infection (e.G.Redness, swelling and with a purulent type substance), the outcome of the pathological analysis was negative.According to patient symptoms, a suspected infection appears to be the only possible reason for the revision surgery.However, the pathological analysis confirmed that no infection was present at the time of revision surgery.With the available info, it's not possible to determine the root cause for the symptoms which are usually related to an infection.This case has not been classified as product-related.(b)(4).No corrective action planned for this specific case.Limacorporate will keep monitoring the market.

Event Description

Smr reverse was implanted on (b)(6) 2016.Revision surgery was done after less than one month (on (b)(6) 2016) from the primary surgery due to following patient symptoms: pain, redness, swelling.Suspected infection.All the prosthesis components were removed and a course of antibiotics was administered to the patient.Event happened in (b)(6).

• Brand Name: SMR FINNED HUMERAL STEMS - 60MM (TI6AL4V) DIA.12MM
• Type of Device: HSD-KWT
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale,52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A.; via nazionale,52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer Contact: giulio puppa
• MDR Report Key: 6383471
• MDR Text Key: 69254763
• Report Number: 3008021110-2017-00016
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1304.15.120
• Device Lot Number: 201505125
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: 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