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 Problem Break (1069)

Patient Problem Toxicity (2333)

Event Date 05/25/2020

Event Type  Injury  

Manufacturer Narrative

By checking the dhr of the lot involved, no pre-existing anomaly was detected on 63 l1 liner manufactured.This is the first and only complaint received on this lot number.Limacorporate will submit a final mdr once the investigation will be concluded.

Event Description

Revision surgery performed on (b)(6) 2020 due to breakage of the l1 liner code (b)(4) (batch #15at13h).Previous surgery was performed on (b)(6) 2016.According to the information provided, patient complained of crunching noise in shoulder.During revision surgery, initial findings were of metallosis and then it was found that the liner was missing but the central peg locking mechanism of the liner was still in situ in the central peg hole.Surgeon commented that cuff was intact but not in the best condition and he also commented that despite the cuff being intact, he was unsure of how effective that cuff would have been working.(b)(6) patient with very high activity level, high fitness level and high motivation (he practices mountain climbing).Event occurred in (b)(6).

Event Description

Revision surgery of a smr anatomic prosthesis performed on (b)(6) 2020 due to breakage of the l1 liner code 1377.50.005 (batch #15at13h).Previous surgery was performed on (b)(6) 2016.According to the information provided, patient complained of crunching noise in shoulder.During revision surgery, initial findings were of metalosis and then it was found that the liner was missing but the central peg locking mechanism of the liner was still in situ in the central peg hole.Surgeon commented that cuff was intact but not in the best condition and he also commented that despite the cuff being intact, he was unsure of how effective that cuff would have been working.84 years old patient with very high activity level, high fitness level and high motivation (mountain climbing).Event occurred in new zealand.

Manufacturer Narrative

By checking the dhr, no pre-existing anomaly was detected on a total of 63 l1 liner manufactured with the same lot# (15at13h).According to our records, at least 48 out of 63 metal back glenoid l1 liners with lot #15at13h and ster.1500326 have been implanted and this is the only complaint received on this lot #.Pictures and the explanted liner were received by limacorporate for analysis.Destructive analysis were conducted in an external chemical laboratory.The liner was analyzed by ftir mapping.According to the received analysis report, "the analysis outcomes reveal an oxidative degradation of the material, probably triggered by mechanical stress, and favored by the presence of diffusion products, for which a pro-oxidative effect was hypothesized.A no-homogeneous oxidative degradation phenomenon was observed for the material, more marked on the articular surface and extended to the bulk for about 3mm.The oxidative degradation is not observed on the area adjacent to the fixing peg, thus it is not believed it is related to the occurred breakage.Probably, both phenomena are attributable to the mechanical stress deriving from the intense activity level of the patient".No additional details were made available on the post-operative issue, specifically the following information was requested to the complaint source, but it was not available: · pre-operative x-rays related to the revision surgery.Based on the received information and on the performed analysis, we can state that the event was not product related, but it was more likely patient factor related.Pms data we are aware of a total of 32 breakages of metal back glenoid l1 liners with codes 1377.50.Xxx (considering breakage due to various causes).On a total of 32 breakages, a total of 14 complaints were classified as patient factor related, giving a specific revision rate of 0,08%.No specific corrective actions implemented in relation to this case.Lima corporate will keep monitored the market to promptly detect any further similar issue.Note: this is a final mdr.

• 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: 10127443
• MDR Text Key: 194348075
• Report Number: 3008021110-2020-00036
• 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: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• 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: 15AT13H
• Date Manufacturer Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention