MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR HUMERAL HEAD Ø50 MM; HUMERAL HEADS (COCRMO) DIA.50MM

Model Number 1322.09.500

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Unspecified Infection (1930)

Event Date 07/28/2021

Event Type  Injury  

Manufacturer Narrative

By checking the sterilization charts of the involved lot #s, no pre-existing anomaly was found on the components with the same lot #s.We will submit a final mdr once the investigation will be completed.

Event Description

Shoulder revision surgery of an smr anatomic implant performed on (b)(6) 2021, due to infection.According to the complaint source, the surgeon performed a thorough wash out and removed the following components: smr humeral head ø50 mm (product code 1322.09.500, lot #1908394 - ster.1900218).Smr eccentrical adaptor taper standard (product code 1330.15.274, lot #1806556 - ster.1800174).Similar components were implanted.It was reported that the humeral head size was reduced due to soft tissue tightening from the previous surgery.Previous surgery took place on (b)(6) 2020.Patient is a male, (b)(6) years old.Event happened in (b)(6).

Event Description

Shoulder revision surgery of an smr anatomic implant performed on (b)(6), 2021, due to infection.According to the complaint source, the surgeon performed a thorough wash out and removed the following components: smr humeral head ø50 mm (product code 1322.09.500, lot #1908394 - ster.1900218) smr eccentrical adaptor taper standard (product code 1330.15.274, lot #1806556 - ster.1800174) an adaptor taper of the same size was implanted.It was reported that the humeral head size was reduced to 48mm due to soft tissue tightening from the previous surgery.Previous surgery took place on (b)(6), 2020.Patient is a male, 69 years old.Event happened in australia.

Manufacturer Narrative

By checking the sterilization charts of the involved lot #s, no pre-existing anomaly was found on the overall number.All the products placed on the market 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: pre-operative x-rays related to the revision surgery; explanted items; 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, stating that the check of 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 anatomic prosthesis due to infection is (b)(4).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.

• Brand Name: SMR HUMERAL HEAD Ø50 MM
• Type of Device: HUMERAL HEADS (COCRMO) DIA.50MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 12369943
• MDR Text Key: 268431468
• Report Number: 3008021110-2021-00060
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1322.09.500
• Device Lot Number: 1908394
• 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): Other