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

Model Number 1377.50.005

Device Problems Migration or Expulsion of Device (1395); Naturally Worn (2988)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 05/13/2021

Event Type  Injury  

Manufacturer Narrative

By checking the manufacturing charts of lot #1403476 and lot #1313939, no anomalies were detected on the products manufactured with the same lot #s.This is the first and only complain received on these 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 pain caused by wear of the liner for metal back glenoid small-r (product code 1377.50.005, lot #1403476 - ster.1400143).It was reported that cuff failure was present and the smr humeral head ø42 mm (product code 1322.09.420, lot #1313939 - ster.1300337) superiorly migrated.It was reported that metallosis was present.The prosthesis was converted to reverse.Previous surgery took place on (b)(6) 2014.Patient is a female.Event happened in (b)(6).

Manufacturer Narrative

Checking the manufacturing charts of the involved lot #1403476, no pre-existing anomaly was found on a total of (b)(4) items manufactured with the same lot #.According to our records, at least 44 out of (b)(4) liners with lot #1403476 - ster.1400143 have been implanted and this is the only complaint received on this lot #.Checking the manufacturing charts of the involved lot #1313939, no pre-existing anomaly was found on a total of (b)(4) items manufactured with the same lot#.According to our records, at least 20 out of (b)(4) humeral heads with lot #1313939 - ster.1300337 have been implanted and this is the only complaint received on this lot #.Explants analysis the items involved were not available to be returned to limacorporate for further analysis.X-rays analysis limacorporate received one x-ray referring to pre-operative revision surgery.The x-ray received - exact date not known - has been evaluated by a medical consultant.Following, the medical consultant comments: "the glenoid component is implanted very low and the rotator cuff failure had led to a relative upward migration of the humeral head.The result is eccentric loading of the liner and subsequent failure.The revision therefore is patient- and procedure-related and rather not implant-related".Considering that: check of the manufacturing charts highlighted no anomalies on the total number of components manufactured with lot #1403476 and lot #1313939; according to the reported information cuff failure was present; according to the medical consultant "the glenoid component is implanted very low and the rotator cuff failure had led to a relative upward migration of the humeral head.The result is eccentric loading of the liner and subsequent failure"; we can state that the event was partially surgical-factor related, partially patient-related.Pms data: according to limacorporate pms data, revision rate of l1 liners - belonging to the family codes 1377.50.0xx - due to wear is 0.11%.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.

Event Description

Shoulder revision surgery of an smr anatomic implant performed on (b)(6) 2021, due to pain caused by wear of the liner for metal back glenoid small-r (product code 1377.50.005, lot #1403476 - ster.1400143).It was reported that cuff failure was present and the smr humeral head ø42 mm (product code 1322.09.420, lot #1313939 - ster.1300337) superiorly migrated.It was reported that metallosis was present.The prosthesis was converted to reverse.Previous surgery took place on (b)(6) 2014.Patient is a female.Event happened in new zealand.

• Brand Name: LINER FOR METAL BACK GLENOID 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: 12007735
• MDR Text Key: 256450381
• Report Number: 3008021110-2021-00045
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1377.50.005
• Device Lot Number: 1403476
• 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