MAUDE Adverse Event Report: LIMACORPORATE S.P.A. GLENOSPHERE DIA. 36 MM

Model Number 1374.09.111

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Pain (1994); Neck Stiffness (2434)

Event Date 05/03/2018

Event Type  Injury  

Manufacturer Narrative

No anomalies detected by checking the manufacturing charts of the smr glenosphere dia.36 mm involved (lot# 201408500) on a total of (b)(4) glenospheres manufactured with the same lot#.No other complaints received on the same lot#.We will send a final emdr once the evaluation will be completed.

Event Description

Shoulder revision surgery due to stiffness and patient pain performed on (b)(6) 2018.According to the info reported, glenoid metal back was placed too high during the primary surgery performed on (b)(6) 2014.This, together with the use of a concentric glenosphere dia.36 mm (size smaller than necessary) caused scapular notching.During the revision, proper stability was achieved by implanting a glenosphere dia.44 mm; connector and liner were also replaced.Event happened in (b)(6).

Event Description

Shoulder revision surgery due to stiffness and patient pain performed on (b)(6) 2018.According to the info reported, glenoid metal back was placed too high during the primary surgery performed on (b)(6) 2014.This, together with the use of a concentric glenosphere dia.36mm (size smaller than necessary) caused scapular notching.During the revision surgery, performed by a different surgeon, proper stability was achieved by implanting an eccentric glenosphere dia.44mm; connector and liner previously implanted were also replaced.Event happened in australia.

Manufacturer Narrative

Check of dhr: no anomalies detected by checking the manufacturing charts of the smr glenosphere dia.36mm involved (lot# 201408500) on a total of 15 glenospheres manufactured with the same lot#.No other complaints received on the same lot#.According to the info provided by complaint source, surgeon responsible for the surgery performed on 20th of november 2014 was inexperienced with the smr system and opted for implanting a smaller than necessary (dia.36mm) concentric glenosphere.In addition, metal back glenoid was at that time implanted in a too high position leading to scapular notching.Since metal back glenoid had solid fixation, surgeon responsible for revision surgery performed on 03rd of may 2018 did not remove it and were able to overcome scapular notching issue by placing an eccentric dia.44mm glenosphere which allowed for good clearance inferiorly.Surgeon responsible for revision surgery explained that no removal of metal back glenoid ensured that solid metal back fixation would be maintained in the future and that, by implanting a 44mm eccentric glenosphere, notching issue was eliminated by providing an articulation 4 mm inferior in respect to the previous implant position.Explants were not available to be returned to limacorporate.According to the info reported, explants were disposed of as per hospital policy.X-rays referring to both pre and post revision surgery (exact date unknown) were provided to limacorporate and evaluated by a lima medical consultant.Following, medical consultant judgment: "i agree the metal back baseplate is very high and this together with the 36mm glenosphere has caused significant impingement.I am not sure that a 44 mm glenosphere is going to eliminate impingement because i am unable to use the software on photo images.I worry a little when there are symptoms that you describe (pain, stiffness) about infection so i hope an appropriate no of specs were taken at revision and that the 44mm glenosphere has eliminated both impingement and symptoms".No additional info about possible infection after performing the revision surgery was provided to limacorporate.Based on the info available and the investigation performed, this case is not product related: a mix of initial malpositioning of the metal back glenoid (too high) and suboptimal choice of glenosphere size was the likely cause for the event reported.Pms data: we are aware of a total of (b)(4) revision surgeries due to pain/stiffness involving smr reverse prosthesis on a total of (b)(4) smr reverse prosthesis implanted ww since 2002.None of the cases reported was classified as product related.Specific revision rate: (b)(4).No corrective action for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issues.

• Brand Name: GLENOSPHERE DIA. 36 MM
• Type of Device: GLENOSPHERE DIA. 36 MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 7544267
• MDR Text Key: 109252097
• Report Number: 3008021110-2018-00038
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K163459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1374.09.111
• Device Lot Number: 201408500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention