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

Model Number 1377.50.020

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 08/21/2020

Event Type  Injury  

Manufacturer Narrative

By checking the dhr of the lot #1314107, no pre-existing anomaly was detected on all the components manufactured with this lot#.We will submit a final mdr once the investigation will be completed.

Event Description

Conversion from smr stemless anatomic to smr stemless reverse prosthesis due to early wear of the polyethylene liner performed on (b)(6) 2020.During the revision surgery, the poly liner previously implanted on (b)(4) 2016; (product code (b)(4), lot #1314107 - ster.1300344) was explanted.Wear of the liner led to a metal-metal contact between glenoid and humeral head components.According to the complaint source, the patient developed without specific reason a squeaky sound in her shoulder and developed pain.There was no identifiable trauma, nor sign of infection.Patient data: female, (b)(6).Event happened in (b)(6).

Manufacturer Narrative

Device history records check: by checking the dhrs of the liners with lot #1314107, no pre-existing anomaly was detected, thus we can state that the involved component was manufactured in compliance to drawings specifications.Explanted component analysis: the explanted components were received by limacorporate.The visual inspection of the liner allowed to confirm that the component is very worn, as reported by the complaint source.Moreover, the peg of the liner appears broken.The conditions of the liner make us believe it remained in situ for some time between the occurrence of the issue and the revision surgery.X-rays analysis: several x-rays were provided by the complaint source and were sent to our medical expert for a clinical evaluation: pre-operative x-rays dated (b)(6) 2015; post-operative x-rays dated (b)(6) 2016; 4 months follow-up x-rays dated (b)(6) 2016; 12 months follow-up x-rays dated (b)(6) 2017; 24 months follow-up x-rays dated (b)(6) 2018 x-rays taken during a visit dated (b)(6) 2020; x-rays taken at the time of the discharge post conversion, dated (b)(6) 2020.All the available images were sent to our medical consultant for a clinical evaluation.His statement is reported below: "the pre- and immediate postop radiographs look normal.After 12m postop there is a sudden superior migration of the humeral head indicative for secondary rotator cuff failure (ssp and/or scp).This lead to imbalance of the joint, edge loading and the well described "rocking horse phenomenon" that lead to early pe wear and/or dissociation.Therefore the reason for revision is patient related and not implant-related." in conclusion, according to the x-rays images evaluation performed by our medical consultant, the cause of the revision surgery is most probably related to patient's secondary rotator cuff failure.This event cannot be classified as product-related.Pms data: based on limacorporate pms data, we can estimate a revision rate due to l1 liners wear of 0,1%.The analyses performed on the previous similar cases, show that in more than 40% of these cases, patient's condition contributed to the l1 liner wear and consequent revision surgery.

Event Description

Conversion from smr stemless anatomic to smr stemless reverse prosthesis due to early wear of the polyethylene liner (product code 1377.50.020, lot #1314107 - ster.1300344).The revision surgery was performed on august 21st, 2020, when the liner, the head (product code 1322.09.480) and the adaptor taper (product code 1355.15.200) were explanted.The previous surgery had been performed on (b)(6) 2016.According to the information received, the patient was satisfied with her shoulder arthroplasty during the last 4 years ("full range of motion-no pain/great patient related outcome measures").Then she developed a squeaky sound in her shoulder and pain, without reporting any identifiable trauma, nor exceptional heavy activity.Patient data: female; born on (b)(6) 1966; 1,70 m, 113 kg, bmi of 39,1 (at the time of the previous surgery).Event happened in nl.

• Brand Name: LINER F. MET.BACK GLEN.SMALL
• Type of Device: LINER FOR METAL-BACK (UHMWPE) LINER SMALL
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 10476737
• MDR Text Key: 214086285
• Report Number: 3008021110-2020-00064
• 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: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1377.50.020
• Device Lot Number: 1314107
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention