MAUDE Adverse Event Report: LIMACORPORATE S.P.A. LINER FOR METAL BACK GLENOID STANDARD; LINER FOR METAL-BACK (UHMWPE) LINER STANDARD

Model Number 1377.50.010

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Fever (1858)

Event Date 11/04/2020

Event Type  Injury  

Manufacturer Narrative

By checking the sterilization charts of the involved products, no pre-existing anomalies were found, thus we can state that all the components had been regularly sterilized before being placed on the market.We will submit a final mdr once the investigation will be completed.

Event Description

Shoulder revision surgery performed on (b)(6), 2020.The primary issue was cuff tear, however the smr uncemented glenoid # std (product code 1375.20.010, lot# 1212299 - ster.1200344) was loose at surgery.According to the complaint source, patient appeared to have a possible low-grade infection only around the glenoid.The following components were removed: liner for metal back glenoid standard (product code 1377.50.010, lot# 1212426 - ster.1200324).Smr uncemented glenoid # std (product code 1375.20.010, lot# 1212299 - ster.1200344) - product not marketed in the us.Bone screw 6,5 h.30mm (product code 8420.15.030, lot# 1212678 - ster.1200337).Bone screw 6,5 h.20mm (product code 8420.15.010, lot# 1206859 - ster.1200239).A cement spacer was inserted.Previous surgery took place on (b)(6) 2012.Patient is a male.Event happened in (b)(6).

Event Description

Shoulder revision surgery of a smr anatomic prosthesis performed on (b)(6) 2020 due to suspected infection.The primary issue was cuff tear, however the smr uncemented glenoid (product code 1375.20.010, lot# 1212299 - ster.1200344) was loose at surgery.According to the complaint source, patient appeared to have a possible low-grade infection only around the glenoid component.The following components were removed: smr uncemented glenoid # std (product code 1375.20.010, lot# 1212299 - ster.1200344) - product not marketed in the us.Liner for metal back glenoid standard (product code 1377.50.010, lot# 1212426 - ster.1200324).Bone screw ø6,5 h.30mm (product code 8420.15.030, lot# 1212678 - ster.1200337).Bone screw ø6,5 h.20mm (product code 8420.15.010, lot# 1206859 - ster.1200239).A cement spacer was inserted.Previous surgery took place on (b)(6) 2012.Patient is a male.Event happened in australia.

Manufacturer Narrative

By checking the sterilization charts of the involved products, no pre-existing anomalies were found, thus we can state that all the components had been regularly sterilized before being placed on the market.No additional details were available on this post-operative issue, specifically the following information was requested by three times to the complaint source, but it was not available: pre-operative x-rays related to the revision surgery; availability of the explants; further details on the infection; pictures of explants.Based on the very few information received, we are not able to further investigate the root cause of the event.However, considering that by the check of the sterilization charts no anomalies were found on the total number of components manufactured with lot #s involved, 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).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: LINER FOR METAL BACK GLENOID STANDARD
• Type of Device: LINER FOR METAL-BACK (UHMWPE) LINER STANDARD
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san dnaiele, udine 33038 ; IT 33038
• MDR Report Key: 10885218
• MDR Text Key: 217686738
• Report Number: 3008021110-2020-00096
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K113254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

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: No Information
• Device Model Number: 1377.50.010
• Device Lot Number: 1212426
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/23/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention