MAUDE Adverse Event Report: LIMACORPORATE S.P.A. LINER F. MET.BACK GLEN.SMALL

Model Number 1377.50.020

Device Problems Defective Device (2588); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 07/05/2018

Event Type  Injury  

Manufacturer Narrative

From the check of the manufacturing chart of the lot #1314107, no dimensional anomalies found on a total of (b)(4) l1 liners manufactured with the same lot#.This is the first and only complaint received on this lot#.We will proceed with further investigations and submit a final mdr once concluded.

Event Description

Total shoulder revision surgery performed on the (b)(6) 2018, due to failure of the liner (code #1377.50.020, lot #1314107).Primary surgery was performed on the (b)(6) 2015.Towards the end of 2016, patient began to suffer pain the shoulder and started to notice a creaking noise coming from it.After seeing several consultants which told him the pain was due to overextending, he was informed in 2018 that the prosthesis had failed due to the polymer used.Event occurred in (b)(6).

Event Description

Total shoulder revision surgery performed on (b)(6) july 2018, due to failure of the poly liner (code #1377.50.020, lot #1314107).Primary surgery was performed on the (b)(6) 2015.According to the info reported, towards the end of 2016, patient started suffering shoulder pain, noticing a creaking noise coming from it.After several medical consultants stating that pain was due to shoulder overextending, at the beginning of 2018 it was stated that prosthesis had failed due to the poly liner previously implanted leading to the revision surgery performed on (b)(6) july 2018.Event happened in uk.

Manufacturer Narrative

Check of dhr: manufacturing records were checked and the batch (1314107) was manufactured correctly up to specs and in-line with the relevant checks and tests.No manufacturing deviations were reported on a total of 71 l1 liners manufactured with the same lot#.First and only complaint received on lot# 1314107.No further info rather than the one reported in the event description were provided to limacorporate.In details, we asked for: - pre-operative and post-operative x-rays related to the primary surgery; - pre-operative and post-operative x-rays related to the revision surgery; - clinical records related to both surgeries; - clinical information about patient (such as age, weight, height) and activity (lifestyle and employment); - availability of explants for further analysis; - info about possible traumatic event; with the only few info received about the case, we cannot investigate deeper.Based on the check of the manufacturing charts, no pre-existing anomalies affected the involved poly liner.Therefore, the case seems to be not product-related.Due to lack of further info, it is unknown if patient factor could have somehow contributed to the event.Pms data: a total of about 15213 l1 poly liners have been sold ww since 2003; according to these data, the total failure rate associated to l1 liners is 0.36%.Only 13 on a total of 47 revision surgeries reported involving l1 liner were classified as product-related, giving a product-related failure of 0.08%.According to the information received, the remaining cases were subsequent to one of the following: patient rotator cuff failure (patient pathology for which the use of a l1 poly liner is not indicated, as reported in our ifu and surgical technique), trauma-related, related to patient condition/practice or surgeon-related.No corrective actions for this case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.

• Brand Name: LINER F. MET.BACK GLEN.SMALL
• Type of Device: LINER F. MET.BACK GLEN.SMALL
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 8398635
• MDR Text Key: 138096797
• Report Number: 3008021110-2019-00019
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 03/07/2019

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: 1377.50.020
• Device Lot Number: 1314107
• Initial Date Manufacturer Received: 02/14/2019
• Initial Date FDA Received: 03/07/2019
• Supplement Dates Manufacturer Received: 02/14/2019
• Supplement Dates FDA Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention