MAUDE Adverse Event Report: LIMACORPORATE SPA SMR CEMENTLESS MINI STEM; SMR CEMENTLESS MINI STEM (HSD-KWT)

Model Number 1304.15.120

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Pain (1994)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

By checking the dhr of the lot #1500641 ster.1500050 no anomaly was detected on a total of 20 stem manufactured with this lot#/ster.This is the first and only complaint received with this lot#.We will submit a final mdr once the investigation will be concluded.

Event Description

Revision surgery due to loosening occurred on (b)(6) 2019.According to the information reported by the complaint source, surgery was initially booked as removal of all smr components due to patient complaints of ongoing pain in left shoulder.Surgeon exposed joint and found that humeral components were loose and stem 1304.15.120 lot #1500641 ster.1500050 rotating within the humeral canal when the arm was manipulated.Surgeon commented that glenoid was well fixed and very stable.It was reported that patient is osteoporotic.Long clinical patient's history can be summarized as follow: primary surgery: date and exact components implanted unknown.First revision surgery on (b)(6) 2018: conversion from anatomic to reverse shoulder prosthesis due to loosening of the metal back glenoid previously implanted.Surgeon commented that patient's bone quality on the inferior glenoid was poor, so planned to position the metal back baseplate a little higher where the bone was better in quality and able to support a metal back glenoid.Second revision surgery on (b)(6) 2019: revision surgery due to loosening of the metal back glenoid.Surgeon decided to implant the glenoid metal back high to improve the stability of the implant because of the better bone quality.Third revision surgery on (b)(6) 2019: open left shoulder reduction due to dislocation.Surgeon performed open reduction and managed to successful reduce the shoulder and commented that it was stable and no components needed to be changed.Fourth revision surgery on (b)(6) 2019 (mfr 3008021110-2019-00036): reason for revision recorded as dislocation.Surgeon removed all humeral components.Surgeon changed version from 20 degrees retroversion to neutral.Surgeon implanted 44mm medium lateralized liner to increase tension on deltoid for stability of joint.Fifth revision surgery on (b)(6) 2019 (current report): revision surgery due to loosening.Surgeon removed humeral components and implanted a new lateralized liner 44mm medium liner, short reverse humeral body and 14mm finned stem.Event happened in (b)(6).

Event Description

Revision surgery due to stem loosening occurred on (b)(6) 2019.According to the information reported by the complaint source, surgery was initially booked as removal of all smr components due to patient complaints of ongoing pain in left shoulder.Surgeon exposed joint and found that humeral components were loose and stem 1304.15.120 lot #1500641 ster.1500050 rotating within the humeral canal when the arm was manipulated.Surgeon commented that glenoid was well fixed and very stable.It was reported that patient is osteoporotic.Long clinical patient's history can be summarized as follow: rimary surgery: date and exact components implanted unknown.First revision surgery on (b)(6) 2018: conversion from anatomic to reverse shoulder prosthesis due to loosening of the metal back glenoid previously implanted.Surgeon commented that patient's bone quality on the inferior glenoid was poor, so planned to position the metal back baseplate a little higher where the bone was better in quality and able to support a metal back glenoid.Second revision surgery on (b)(6) 2019: revision surgery due to loosening of the metal back glenoid.Surgeon decided to implant the glenoid metal back high to improve the stability of the implant because of the better bone quality.Third revision surgery on (b)(6) 2019: open left shoulder reduction due to dislocation.Surgeon performed open reduction and managed to successful reduce the shoulder and commented that it was stable and no components needed to be changed.Fourth revision surgery on (b)(6) 2019 (mfr 3008021110-2019-00036): reason for revision recorded as dislocation.Surgeon removed all humeral components.Surgeon changed version from 20 degrees retroversion to neutral.Surgeon implanted 44mm medium lateralized liner to increase tension on deltoid for stability of joint.Fifth revision surgery on (b)(6) 2019 (current report): revision surgery due to loosening.Surgeon removed humeral components and implanted a new lateralized liner 44mm medium liner, short reverse humeral body and 14mm finned stem.Event occurred in australia.

Manufacturer Narrative

Check of the dhr: by checking the dhr of the lot #1500641 ster.1500050 no pre-existing anomaly was detected on a total of 20 stems manufactured with this lot#/ster.Furthermore, 19 out of 20 stems manufactured have been already implanted without receiving any additional complaint.Xrays analysis: we received pre-operative xrays dated (b)(6) 2019 and sent them to our medical consultant for clinical investigation.Following, his analysis is reported: "a fifth revision with a loose humeral component is infected until proven otherwise.That said while the images are not good quality there is not much evidence of loosening.The "high" position of the glenoid will obviously result in impingement which will impart abnormal stresses on the implantation and could be associated with aseptic loosening and especially given that the humeral component is either a 12mm or 13mm stem which are not inherently as mechanically fixed as the larger stems." the medical consultant, on the basis of pre-revision xrays, identified the following two possible causes for stem loosening: a possible infection due to the several surgeries received, which could have led to loosening of the stem.However, complaint source reported that the explants were not taken for culture and were simply disposed of by the scrub nurse after the case; the high positioning of the glenoid, which could have resulted in impigment that would have imparted abnormal stresses on the implantation.This possibility together with the use of a mini stem, could have favoured implant loosening.In conclusion, considering the analysis provided by the medical consultant and the fact that it was verified that all the stems manufactured with lot #1500641 were up to specifications, we can conclude that the event was due to a combination of clinical factor(the several surgeries received) and surgical factor (suboptimal positioning).Pms data: according to our pms data, revision rate of smr system due to loosening of the cementless stem with family of code 1304.15.Xxx is 0.007%.None of these cases was judged as product related.No corrective/preventive actions performed on this specific case.Limacorporate will keep the market monitored.

• Brand Name: SMR CEMENTLESS MINI STEM
• Type of Device: SMR CEMENTLESS MINI STEM (HSD-KWT)
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 9415906
• MDR Text Key: 184862383
• Report Number: 3008021110-2019-00139
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K101263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 05/06/2020

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: 1304.15.120
• Device Lot Number: 1500641
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 11/25/2019
• Supplement Dates FDA Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention