MAUDE Adverse Event Report: LIMACORPORATE SPA SMR HUMERAL HEAD Ø40 MM; HUMERAL HEADS (COCRMO) DIA.40MM (KWT, HSD)

Model Number 1322.09.400

Device Problem Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 08/08/2018

Event Type  Injury  

Manufacturer Narrative

From the check of the manufacturing charts of the lot #s involved: no pre- existing anomaly was found on the 74 humeral heads (code 1322.09.400) placed on the market with lot# 1414308; no pre- existing anomaly was found on the 59 metal back glenoid (code 1375.20.010) placed on the market with lot# 1406731.We will investigate further and submit a final mdr once concluded.

Event Description

Smr revision surgery due to cuff failure performed on (b)(6) 2018.Previous surgery performed by a different surgeon on (b)(6) 2017.During revision surgery a smr reverse was implanted.According to the second surgeon, cuff failure is probably associated with poor positioning of the metal back glenoid (code 1375.20.010, lot# 1406731) which was too anteverted and led to excessive force being placed on subscapularis tendon.Surgeon was satisfied with final stability and rom.Event happened in (b)(6) metal back glenoid involved in this case is not marketed in the usa, only the humeral head is.

Event Description

Shoulder conversion from smr anatomic total to smr reverse performed on (b)(6) 2018 due to cuff failure.According to the info reported, conversion performed on (b)(6) 2018 was not the first "revision surgery" for this patient.Summary of the patient's clinical history as per following: - primary surgery on (b)(6) 2014.During this surgery, a smr anatomic total was implanted.In details, metal back glenoid code 1375.20.010 lot# 1406731, humeral head dia.42mm code 1322.09.420, lot# 1407219, liner std code 1377.50.010, lot 1401103 and humeral body code 1350.15.110, lot# 1404124 were implanted; - first revision surgery on (b)(6) 2017.Root cause for this revision surgery was not reported but during this surgery a humeral head dia 40mm (code 1322.09.400, lot# 1414308) and a trauma short humeral body (code 1350.15.030, lot# 1518945) were implanted (possible fracture?).Surgeon responsible for this revision surgery was the same of the one responsible for primary surgery; - conversion from smr anatomic total to smr reverse on (b)(6) 2018.Surgeon responsible for the conversion (different from the one responsible for the previous surgeries) believed that metal back glenoid originally implanted on (b)(6) 2014 was implanted in an anteverted position resulting in excessive force on the subscapularis tendon.Poor primary implant positioning was probably the main cause for the cuff failure reported.During the conversion, a 40mm glenosphere and a medium liner were implanted.Surgeon satisfied with final stability of the implant.Event happened in australia.

Manufacturer Narrative

Check of dhr: from the check of the manufacturing charts of the lot numbers involved: - no pre-existing anomaly was found on a total of 74 humeral heads (code 1322.09.400) placed on the market with lot# 1414308 (same lot of the one implanted during the revision surgery performed on (b)(6) 2017); - no pre-existing anomaly was found on a total of 59 metal back glenoid (code 1375.20.010) placed on the market with lot# 1406731 (same lot# of the one implanted during the primary surgery dated (b)(6) 2014).No other complaints reported on the glenoid metal back lot# involved (1406731).Explants analysis: no explants available to be returned to limacorporate.According to the info reported, explants were disposed of as per hospital policy.X-rays analysis: no x-rays available for limacorporate analysis, no referring to primary surgery nor referring to the other surgeries performed in time.With only the few info provided available, it is not possible to conduct a very deep analysis on this case.We cannot go back with certainty to the root cause of the cuff failure reported, especially because with no post-op primary surgery xrays available limacorporate can only speculate that poor primary implant (suboptimal implant of the metal back glenoid during (b)(6) 2017 surgery) could have been the cause for the cuff failure.Failure surgical factor related as reported per surgeon (responsible for conversion) notes.Pms data: we are aware of a total of 3 conversion from smr anatomic total to smr reverse due to poor primary implant positioning on a total of more than 23000 smr anatomic total implants performed ww.Specific revision rate:(b)(4).No corrective action for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.

• Brand Name: SMR HUMERAL HEAD Ø40 MM
• Type of Device: HUMERAL HEADS (COCRMO) DIA.40MM (KWT, HSD)
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 7812185
• MDR Text Key: 118090489
• Report Number: 3008021110-2018-00069
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1322.09.400
• Device Lot Number: 1414308
• Date Manufacturer Received: 08/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention