MAUDE Adverse Event Report: LIMACORPORATE SPA SMR HUMERAL HEAD 50 MM; SMR HUMERAL HEAD Ø50 MM(KWT, HSD)

Model Number 1322.09.500

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); No Code Available (3191)

Event Date 06/12/2020

Event Type  Injury  

Manufacturer Narrative

By checking the dhr of the lot#1609741, no pre-existing anomaly was detected on 62 humeral heads manufactured with this lot.We will submit a final mdr once the investigation will be completed.

Event Description

Conversion from smr anatomic to smr reverse system due to posterior dislocation occurred on (b)(6) 2020.Previous surgery was performed on (b)(6) 2017.According to the information reported, patient dislocated during sleep for unknown cause.Patient subscapularis and suprascapularis were insufficient.During revision, the humeral head (product code 1322.09.500, lot#1609741), the adaptor, the liner and the humeral body were replaced.Event occurred in (b)(6).

Event Description

Conversion from smr anatomic to smr reverse system due to posterior dislocation occurred on (b)(6) 2020.Previous surgery was performed on (b)(6) 2017.According to the information reported, patient dislocated during sleep for unknown cause.Patient subscapularis and suprascapularis were insufficient.During revision, the humeral head (product code: 1322.09.500, lot#: 1609741), the adaptor, the liner and the humeral body were replaced and smr anatomic was converted to reverse.It was reported that the patient is a small female, low body weight with low muscle mass.Event occurred in australia.

• Brand Name: SMR HUMERAL HEAD 50 MM
• Type of Device: SMR HUMERAL HEAD Ø50 MM(KWT, HSD)
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 10188908
• MDR Text Key: 199847060
• Report Number: 3008021110-2020-00048
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1322.09.500
• Device Lot Number: 1609741
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention