MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR CTA HUMERAL HEAD 42 MM; CTA HUMERAL HEADS (COCRMO) DIA.42MM

Model Number 1323.09.420

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Loss of Range of Motion (2032); No Code Available (3191)

Event Date 08/05/2020

Event Type  Injury  

Manufacturer Narrative

By checking the dhr of the lot#s 1517478 and 1414174, no pre-existing anomalies were detected on all the components manufactured with these lot #s.This is the first and only complaint received on these lot numbers.We will submit a final mdr once the investigation will be completed.

Event Description

Revision surgery due to loss of range of motion performed on (b)(6) 2020.During previous surgery an anatomic hemi was implanted.The reason for this implant was that, despite surgeon's attempts, during previous surgery nor a metal back with one screw, nor a 3-peg cemented implant were stable on the glenoid.Therefore, the result of the primary surgery was a cta head implanted into a bare bone glenoid.The surgeon has suggested that maybe the original guide wire placement for the glenoid preparation was inaccurate.During revision surgery the smr cta humeral head 42 mm (product code 1323.09.420, lot# 1517478 - ster.1500377) and the smr cta heads adaptor 36 mm (product code 1352.15.200, lot# 1414174 - ster.1500052) were explanted.Primary surgery took place on (b)(6) 2018.Event happened in (b)(6).

Manufacturer Narrative

By checking the dhr of the lot numbers 1517478 and 1414174, no pre-existing anomalies were detected on all the components manufactured with these lot #s.This is the first and only complaint received on these lot numbers.Explants were not available to be returned to limacorporate for further investigation.We received a picture of the explants and a single x-ray referring to the pre-op revision surgery.We asked to our medical consultant for a medical evaluation of the case.Following, the comments received: "there is no surgeon ever in the history of the world who has not made a mistake but looking at the xray this would appear to be a "straightforward" primary procedure? indeed the revision surgeon is likely correct and there is no debate that a critical part of the procedure is getting the guide wire position right.Get it wrong and there is no going back unless you "start again".So for the primary surgeon who got into trouble my advice would be: when you realise things are going wrong, stop, tell the or team you are having difficulty, and go to the phone and ring a colleague.When things go wrong the surgeon doesn't always think well and talking the problem over with a colleague can help.I do not criticise the surgeon for having a problem, but he likely would have done better during the index procedure if he had asked for help.Sadly a cta head as a generalization has a poor outcome.The revision surgeon has salvaged the situation which is good but we could have a debate on the merit of choosing a "hybrid" (mixed of lima and competitor prosthesis) of components".Despite the medical consultant's judgement, our local subsidiary made us aware that the surgeon responsible for the primary surgery was a hip specialist.Based on the investigation performed we can conclude this complaint was surgical factor related.Pms data: according to our pms data, revision rate of cta humeral heads - belonging to the family codes 1323.09.Xxx - 1323.15.Xxx - due to pain and loss of range of motion is 0.08 %.None of the events we could investigate was classified as product-related.No specific corrective actions for this case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.

Event Description

Revision surgery of a cta hemi prosthesis due to loss of range of motion performed on (b)(6), 2020.During previous surgery, performed on (b)(6), 2018, a smr anatomic hemi was implanted.The reason for this implant was that, despite surgeon's attempts, during previous surgery nor a metal back with one screw, nor a 3-peg cemented implant were stable on the glenoid.Therefore, the result of the primary surgery was a cta humeral head implanted into a bare bone glenoid.The surgeon responsible for the revision surgery (different from the surgeon responsible for the primary surgery) has suggested that maybe the original guide wire placement for the glenoid preparation was inaccurate.During revision surgery the smr cta humeral head ø42 mm (product code 1323.09.420, lot# 1517478 - ster.1500377) and the smr cta heads adaptor ø36 mm (product code 1352.15.200, lot# 1414174 - ster.1500052) were explanted.Event happened in australia.

• Brand Name: SMR CTA HUMERAL HEAD 42 MM
• Type of Device: CTA HUMERAL HEADS (COCRMO) DIA.42MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele; udine 33038 ; IT 33038
• MDR Report Key: 10453402
• MDR Text Key: 204619076
• Report Number: 3008021110-2020-00055
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K110847
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1323.09.420
• Device Lot Number: 1517478
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention