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 Installation-Related Problem (2965); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 09/29/2021

Event Type  Injury  

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly was found on the liners released with lot number 19at0tp.This is the first and only complaint received on the same lot number.A final report will be submitted after the conclusion of the investigation.

Event Description

Revision surgery due to disassembly of the liner (code 1377.50.005, lot 19at0tp) from the metal back glenoid.The revision surgery took place on (b)(6) 2021, while the previous surgery was performed on (b)(6) 2019.Patient data: male, (b)(6), 194 cm, (b)(6), retired with low activity level.Event occurred in (b)(6).

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly was found on the 49 liners that belong to lot number 19at0tp, therefore we can state they have been manufactured up to drawings specifications and in line with the relevant check and tests.According to our records, 29 liners that belong to lot number 19at0tp have already been implanted and this is the first and only complaint received on the same lot number.Several ct and x-rays images referring to the involved patient (taken between year 2019 and year 2021) were received by limacorporate.The images were analyzed by a medical consultant, together with the photo of the explanted devices.He commented: "the radiographs show a first slow but than remarkable superior migration of the humeral component ((b)(6) 2019, (b)(6) 2020, (b)(6) 2021).This is probably due to rotator cuff insufficiency, one of the major reasons for tsa failure, need for revision and conversion to rsa.This would than be a fateful course of events.The liner breakage and disassembly would therefore be the consequence and not the cause of the problem.The explant look unremarkable, as far as i can see.In conclusion patient and/or procedure related issues are most likely the reason for revision, implant associated issues are possible, but very unlikely." conclusion and pms data the x-rays analysis performed highlighted a progressive humeral head migration over time.This failure modality, makes us believe that that the main factor that led to this revision surgery could be related to patient's rotator cuff insufficiency.Based on limacorporate pms data, we estimate a revision rate of the l1 liners (product codes 1377.50.005-010-020-030) due to breakage and/or disassembly from the metal back glenoid of about 0,27%.No corrective action is needed following this complaint.Limacorporate will continue monitoring the market to promptly detect any further similar event.

Event Description

Revision surgery of smr stemless prosthesis due to breakage and disassembly of the polyethylene liner (product code 1377.50.005, lot 19at0tp, ster.1900225) from the metal back glenoid (product code 1375.20.005, lot number 1908787, ster.1900226).The complaint source reported pain, squeaking of prosthesis, with increasing symptoms and decrease in movement since 20th of july 2021.It was also reported that "pre-operatively severe metallosis was seen" and "ct scan showed thinning of the pe".The revision surgery took place on 29th september 2021, while the previous surgery was performed on (b)(6) 2019.During the revision surgery, the prosthesis was converted to smr stemless reverse, without removal of the metal back component.Patient data: male, 64 years old, 194 cm, 104 kg, retired with low activity level.This event occurred in the netherlands.Note: smr stemless system is not cleared in the usa; the specific component involved in the complaint is available in the usa as part of the smr anatomic system.

• 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 naizonale 52; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via naizonale 52; villanova di san daniele, udine 33038
• MDR Report Key: 12915721
• MDR Text Key: 283156957
• Report Number: 3008021110-2021-00098
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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 Model Number: 1377.50.005
• Device Lot Number: 19AT0TP
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/21/2022
• 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