MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR HUMERAL HEAD 52 MM; HUMERAL HEADS (COCRMO) DIA.52MM

Model Number 1322.09.520

Device Problem Degraded (1153)

Patient Problem Failure of Implant (1924)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

By checking the dhr of the lot #0703348, no pre-existing anomaly was detected on all the components manufactured with this lot #.We will submit a final mdr once the investigation will be completed.

Event Description

Revision surgery performed on (b)(6) 2020 due to cuff failure.It was reported a deterioration in patient's cuff with time.The following components were explanted: smr humeral head 52 mm (product code 1322.09.520, lot# 0703348 - ster.1300160) smr ecc.Adaptor taper standard (product code 1330.15.278, lot# 1211492 - ster.1200341).Smr finned humeral body (product code 1350.15.110, lot# 1305943 - ster.1300229).Liner f.Met.Back glen.Standard (product code 1377.50.010, lot# 1308189 - ster.1300228).According to the complaint source, the stem and the metal back were solid and left in situ.The implant was converted to reverse.Previous surgery took place on (b)(6) 2013.Patient is a male, born on (b)(6).Event happened in (b)(6).

Event Description

Conversion from smr anatomic total to smr reverse prosthesis performed on (b)(6) 2020 due to cuff failure.It was reported a deterioration in patient's cuff with time.The following components were explanted: · smr humeral head ø52 mm (product code 1322.09.520, lot# 0703348 - ster.1300160) · smr ecc.Adaptor taper standard (product code 1330.15.278, lot# 1211492 - ster.1200341), · smr finned humeral body (product code 1350.15.110, lot# 1305943 - ster.1300229), · liner f.Met.Back glen.Standard (product code 1377.50.010, lot# 1308189 - ster.1300228).According to the complaint source, the humeral stem and the metal back glenoid were solid and left in situ.Surgeon commented that the pe liner was very worn, and the mb was solid but its postosuperior lug was worn.Previous surgery took place on (b)(6) 2013.Patient is a male, born on (b)(6) 1957.Event happened in australia.

Manufacturer Narrative

By checking the dhr of the lot #0703348, no pre-existing anomaly was detected on all the components manufactured with this lot #.Explants analysis: explanted components not available to be returned to hq.The hospital does not permit return of explanted prostheses as per their policy.X-rays analysis: we received some pre-operative x-rays taken on september 21st, 2020 + some pictures of the explants showing the liner's wear.We asked for a clinical evaluation of the case to our medical consultant.Following, his statement: "the underlying cause of failure of the tsa is rotator cuff insufficiency, which is one of the main leading reasons for revision of tsa.It is related to age and other specific factors.The insufficient supraspinatus tendon is clearly visible which lead to the superior migration.The glenoid metalback seems to be positioned very inferiorly for a tsa, this position might be optimal for rsa, but not for tsa.The reason for revision therefore is disease- and procedure-related and not implant-related".Based on the investigation performed, we can conclude that contributory causes for the failure of the smr anatomic total prosthesis involved are both patient factor and surgical factor.Event not product related.Pms data: according to lima corporate pms data, we can estimate a revision rate of smr anatomic total prosthesis due to cuff failure of 0,56%.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 report.

• Brand Name: SMR HUMERAL HEAD 52 MM
• Type of Device: HUMERAL HEADS (COCRMO) DIA.52MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 10725866
• MDR Text Key: 213490999
• Report Number: 3008021110-2020-00088
• 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: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1322.09.520
• Device Lot Number: 0703348
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention