MAUDE Adverse Event Report: LIMACORPORATE SPA LINER F.MET.BACK GLEN.STANDARD 2; LINER FOR METAL-BACK (UHMWPE) LINER STANDARD

Model Number 1377.50.010

Device Problems Break (1069); Appropriate Term/Code Not Available (3191); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Toxicity (2333)

Event Date 04/06/2020

Event Type  Injury  

Manufacturer Narrative

By the check of the dhrs no pre-existing anomaly was found on the liners with code 1377.50.010 and lot 17at0ue nor on the metal back glenoids with code 1375.20.010 and lot# 1708566 (the metal back glenoids with code 1375.20.010 are not marketed in usa).First and only complaint received on these lot#s.We will submit a final mdr as soon as the investigation will be completed.

Event Description

Smr stemless revision surgery performed on (b)(6) 2020.Previous surgery took place on (b)(6) 2017.According to the info received, the cause of the revision was related to "insufficiency of the metal backed glenoid component (despite the fact that the superior cuff was intact by ultrasound and peroperatively) and the metal backed issue".It was reported to us that the central peg of the poly liner was broken and the liner was loose due to the disappearance of the cranial rim of the metal backed glenoid component with a metal-metal articulation (and metallosis) as a result.The patient experienced a fall 2/3 weeks before the visiting date ((b)(6) 2020).The metal back glenoid was not replaced and a conversion to stemless reverse was performed.Patient's data: male; dob (b)(6); (b)(6) kg; 189 cm, intense activity level.Event happened in (b)(6).

Manufacturer Narrative

Dhr check: no pre-existing anomaly was detected by the check of the dhrs of the (b)(4) liners that belong to lot# 17at0ue, thus we can state that the involved component was manufactured up to the specifications, no deviation detected.According to our records, at least (b)(4) liners with the same lot# have already been implanted without receiving further complaints on them.Explant analysis: by a visual inspection, we could confirm that the liner edge is visibly damaged and the peg is broken.The analysis of the retrieved liner was performed in an external laboratory, in order to establish if chemical alterations connected with the liner breakage had occurred.The following analysis were performed:atr ftir (attenuated total reflectance-fourier transform infrared spectroscopy) to evaluate possible chemical alterations occurred on sample surface; ftir (fourier-transform infrared spectroscopy) to evaluate possible chemical alterations occurred within the sample.Atr ftir analysis was performed on the peg surface (fracture site and nearby the fracture site) and on the articular surface of the liner, nearby the most damaged area.In both cases, in addition to the typical signals of polyethylene, only weak/very weak absorptions centered around 1736 and 1660 cm-1 can be observed, respectively attributable to fatty acids esters and protein material, diffused or adsorbed on the polyethylene in vivo.Ftir analysis was performed on the liner section, in order to detect possible oxidative degradation phenomena of the material.Near the articular surface only absorptions (1736 cm-1) related to the diffusion of esters present in the synovial fluid can be observed.The alterations observed do not affect the mechanical behavior of the material and are not related to the liner breakage and wear rate.Xrays analysis: the following xrays images were provided by the complaint source and analyzed by our medical expert, together with some pictures of the explanted components: pre-operative xrays dated (b)(6) 2017; xrays taken at the time of discharge (after primary surgery) (b)(6) 2017; xrays taken at 4 months follow up visit (b)(6) 2018; xrays taken at 12 months follow up visit (b)(6) 2018; xrays taken at 24 months follow up visit (b)(6) 2019; xrays taken at the time of discharge (after revision surgery) (b)(6) 2020.The following comments were pointed out by our medical expert: the pre-operative images show an osteopathic arthropathy with mild humeral bone stock loss, and no glenoid bone stock loss; the post-operative images of the primary surgery show a metal back glenoid which is a "few" mm too low; the humeral component is stemless in optimal position; the humeral head could be little larger and slightly thicker (but with the stemless configuration there is no implant available for that); the explanted poly liner shows the characteristic wear postero-superiorly; the failure was although the best humeral head implant available was selected it was "too thin" and thus the capsule was "loose" and allowed progressive postero-superior migration of the humeral head; about the fall experienced by the patient, the only detail available is that the patient's shoulder was suddenly and significantly worse, so it should be included in the factors causing the failure; in conclusion, the retrieved liner analysis confirmed that the breakage/wear of the component was not due to chemical alteration of the material itself.In addition, the check of the dhrs confirmed the absence of pre-existing anomaly on the components with the same lot#.According to our analysis, we cannot go back with certainty to the root cause of the issue reported, but we can speculate that the following factors could have contributed: the glenoid baseplate positioning (slightly too low), which could have contributed to a possible overload on the liner edge; the implant chosen (humeral head slightly "too thin"); the fall experienced by the patient.Based on these results, we cannot classify the event as product-related.Pms data: according to our pms data, the revision rate of the l1 liners (codes 1377.50.005-1377.50.020-1377.50.010-1377.50.030) due to liner dissociation and/or breakage is (b)(4).In more of the 40% of these cases, trauma or patient's cuff failure were reported as contributory factors.No specific action for this case, limacorporate will continue monitoring the market to promptly detect any further similar event.

Event Description

Smr stemless revision surgery performed on (b)(6) 2020.Previous surgery took place on (b)(6) 2017.During the revision surgery, the implant was converted to stemless reverse.The cause of the revision reported by the complaint source was the following: "insufficiency of the metal backed glenoid component (despite the fact that the superior cuff was intact by ultrasound and peroperatively) and the metal backed issue".The complaint source reported that the central peg of the poly liner was broken and the liner was loose due to the disappearance of the cranial rim of the metal back glenoid component with a metal-metal articulation (and metallosis) as a result.According to the information received, the metal back glenoid was damaged, but it was decided not to remove it as the glenosphere could be firmly attached to the metal back component ("despite the disappereance of the superior rim of the metal baked").It was also reported that the metal back glenoid and the stemless core were not loose.Moreover, according to the information received, the patient sustained an injury with a fall on his left shoulder between 2 till 3 weeks prior to the visiting date ((b)(6) 2020).Since then, he had lost active elevation above shoulder level and experienced a squeaky noise in his left shoulder.Patient's data: male; dob (b)(6) 1948; 122kg; 189cm, intense activity level.Event occurred in netherlands.Note: the stemless system is not marketed in us (l1 liners are marketed in us to be used with smr anatomic prosthesis).

• Brand Name: LINER F.MET.BACK GLEN.STANDARD 2
• Type of Device: LINER FOR METAL-BACK (UHMWPE) LINER STANDARD
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 9985007
• MDR Text Key: 196821677
• Report Number: 3008021110-2020-00023
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1377.50.010
• Device Lot Number: 17AT0UE
• Date Manufacturer Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention