MAUDE Adverse Event Report: LIMACORPORATE S.P.A. LINER F. MET.BACK GLEN.SMALL-R; LINER FOR METAL-BACK (UHMWPE) LINER SMALL-R

Model Number 1377.50.005

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Toxicity (2333)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

By checking the dhr of the lot #15at07u, no pre-existing anomaly was detected on all the components manufactured with this lot #.This is the first and only complaint received on this lot number.We will submit a final mdr once the investigation will be completed.

Event Description

Shoulder revision surgery performed on (b)(6) 2020: the liner f.Metal back glenoid small-r (product code: (b)(4), lot# 15at07u - ster.1500148) was found no longer in correct position.It was reported that this had caused the humeral head implant to be in direct contact with the baseplate.According to the complaint source, the patient exhibited significant signs of metallosis under the humeral head and surrounding the baseplate on the soft tissue.The following components: liner f.Metal back glenoid small-r (product code: (b)(4), lot# 15at07u - ster.1500148).Smr humeral head d.48 h.20mm (product code: (b)(4), lot# 1613841 - ster.1600304).Smr eccentrical adaptor taper standard (product code: (b)(4), lot# 1712463 - ster.1700373).Smr finned humeral body (product code: (b)(4), lot# 1706269 - ster.1700216) were explanted and the implant converted to reverse.Previous surgery on (b)(6) 2018.Patient is a female, (b)(6)-years old.Event happened in the us.

• Brand Name: LINER F. MET.BACK GLEN.SMALL-R
• Type of Device: LINER FOR METAL-BACK (UHMWPE) LINER SMALL-R
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 10783809
• MDR Text Key: 216853296
• Report Number: 3008021110-2020-00093
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K113254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 11/02/2020

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 Operator: No Information
• Device Model Number: 1377.50.005
• Device Lot Number: 15AT07U
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/04/2020
• 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