MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR HUMERAL HEAD Ø48 MM; HUMERAL HEADS (COCRMO) DIA.48MM

Model Number 1322.09.480

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/04/2020

Event Type  Injury  

Manufacturer Narrative

By checking the dhr of the lot #1506370 and #1602696, no pre-existing anomalies were detected on the pieces manufactured with these lot #s.This is the first and only complaint received on these lot #s.We will submit a final mdr once the investigation will be completed.

Event Description

Shoulder revision surgery performed on (b)(6) 2020.It was reported that the glenoid liner's peg broke (product code and lot number unknown), dislodging the liner from the metal back glenoid.According to the complaint source, the head and metal back were metal to metal.The following components were explanted: smr humeral head ø48 mm (product code 1322.09.480, lot# 1506370).Smr eccentrical adaptor taper standard (product code 1330.15.274, lot# 1602696 - ster.1600114).According to the received information, the metal back and stem were left in place.The implant was converted to reverse.Previous surgery took place on (b)(6) 2020.Event happened in the us.

Manufacturer Narrative

Investigation: by checking the dhr of the lot numbers 1506370 and 1602696, no pre-existing anomalies were detected on the pieces manufactured with these lot numbers.According to our records, at least 58 out of 64 smr humeral heads belonging to the lot number 1506370 have been implanted and at least 48 out of 51 smr adaptor tapers belonging to the lot number 1602696 have been implanted and this is the first and only complaint received on these two lot numbers.The components involved in the event were available to be returned to the manufacturer.Based on the visual inspection of the components, it is highly probable that the revision surgery was due the failure of the patient's rotator cuff.In fact, the liner shows wear that leads to the conclusion that it has migrated as a result of rotator cuff failure.No additional information has been provided by the complaint source, such as radiographs, therefore we are not able to further investigate the event.However, based on the following evidence: no pre-existing anomaly have been discovered by checking the manufacturing charts of the lot numbers involved in the event; the internal investigation pointed out that the most likely reason for the revision surgery is a rotator cuff failure.We can conclude that the event is not product-related.Pms data: according to the relevant pms data, the revision rate of smr humeral heads belonging to the family product code 1322.09.Xxx due to breakage of component is around (b)(4).Based on the root cause analysis performed and according to the relevant pms data, no corrective actions required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.Note: this is a final mdr.

Event Description

Shoulder revision surgery performed on (b)(6) 2020.It was reported that the peg of the glenoid liner broke (product code and lot number unknown), dislodging the liner from the metal back glenoid.According to the complaint source, the head and metal back were metal to metal.The following components were removed: smr humeral head ø48 mm (part code 1322.09.480, lot number 1506370, sterilization 1500228).Smr eccentrical adaptor taper standard (part code 1330.15.274, lot number 1602696, sterilization 1600114).According to the received information, the metal back and stem were left in place.The implant was converted to reverse.The previous surgery took place on september 14th, 2020.Event happened in the united states.

• Brand Name: SMR HUMERAL HEAD Ø48 MM
• Type of Device: HUMERAL HEADS (COCRMO) DIA.48MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 11626294
• MDR Text Key: 261274497
• Report Number: 3008021110-2021-00028
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2024

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 Model Number: 1322.09.480
• Device Lot Number: 1506370
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/30/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention