MAUDE Adverse Event Report: LIMACORPORATE S.P.A. LINER F. MET.BACK GLEN.SMALL-R; LINER FOR METAL-BACK (UHMWPE) LINER SMALL-R

Model Number 1377.50.005

Device Problems Naturally Worn (2988); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Toxicity (2333)

Event Date 08/12/2020

Event Type  Injury  

Manufacturer Narrative

By checking the dhr of the lot# 1203958, no pre-existing anomalies were detected on all the components manufactured with this lot #.This is the first and only complaint received on this lot number.We will submit a final mdr once the investigation will be completed.

Event Description

Revision surgery of a smr anatomic total prosthesis due to cuff failure performed on (b)(6) 2020.The patient had a history of 3 months of pain.The surgeon suspected that the pain was likely due to the damaging effects of the metalosis, not to the cuff failure.Indeed, upon exposing the joint, the glenoid poly liner was found asymmetrically worn, resulting in a metal on metal contact between the humeral head and the metal back glenoid, eventually causing metalosis.The anatomic components: smr humeral head ø46 mm, product code 1322.09.460, lot# 1204790 - ster.1200173 liner f.Met.Back glen.Small-r, product code 1377.50.005, lot# 1203958 - ster.1200179 neutral adaptor taper standard, product code 1330.15.270, lot# 1201696 - ster.1200047.Smr finned humeral body, product code 1350.15.110, lot# 1200253 - ster.1200086 were explanted, and replaced with the reverse shoulder components.The components were previously implanted on (b)(6) 2012.Event happened in (b)(6).

Manufacturer Narrative

By checking the manufacturing charts of the involved lot#, no pre-existing anomaly was found on a total of 45 items manufactured with the same lot#.According to our records, at least 44 out of 45 glenoid liners with lot #1203958 have been implanted and this is the only complaint received on this lot #.Explants were not available to be returned to limacorporate for further analysis.X-rays analysis limacorporate received one ct scan referring to pre-op revision surgery.The ct scan received - exact date not known - has been evaluated by a medical consultant.Following, the medical consultant comments: "the underlying cause of failure of the tsa is rotator cuff insufficiency, which is one of the main leading reasons for revision of tsa.It is related to age and other specific factors.The insufficient supraspinatus tendon is clearly visible which lead to the superior migration.The reason for revision therefore is disease-related and not implant-related".Based on the investigation performed we can conclude this complaint was patient factor related.Pms data: according to lima corporate pms data, we can estimate a revision rate of smr anatomic total prosthesis due to cuff failure to be 0,56%.No specific corrective actions for this case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.With respect to the initial report, the investigation had been focused on the liner f.Met.Back glen.Small-r (product code 1377.50.005, lot# 1203958 - ster.1200179).For this reason, in the final report the suspected code had been updated to the one of the liner.

Event Description

Revision surgery of a smr anatomic total prosthesis due to cuff failure performed on (b)(6) 2020.The patient had a history of 3 months of pain.According to the complaint source, the surgeon suspected that the pain was likely due to the damaging effects of the metalosis, not to the cuff failure.Indeed, upon exposing the joint, the glenoid poly liner was found asymmetrically worn, resulting in a metal on metal contact between the humeral head and the metal back glenoid, eventually causing metalosis.The anatomic components: liner f.Met.Back glen.Small-r, product code 1377.50.005, lot# 1203958 - ster.1200179; smr humeral head ø46 mm, product code 1322.09.460, lot# 1204790 - ster.1200173; neutral adaptor taper standard, product code 1330.15.270, lot# 1201696 - ster.1200047.Smr; finned humeral body, product code 1350.15.110, lot# 1200253 - ster.1200086; were explanted and replaced with the reverse shoulder components.The components were previously implanted on (b)(6) 2012.Patient is a female, 69 years old.Event happened in australia.

• Brand Name: LINER F. MET.BACK GLEN.SMALL-R
• Type of Device: LINER FOR METAL-BACK (UHMWPE) LINER SMALL-R
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 10435576
• MDR Text Key: 212510032
• Report Number: 3008021110-2020-00059
• 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: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1377.50.005
• Device Lot Number: 1203958
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention