MAUDE Adverse Event Report: LIMACORPORATE S.P.A. DELTA TT ACETABULAR CUP

Model Number 5552.15.540

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

The check of the dhr of the lot # involved (201508363) showed no anomalies on the 49 delta tt acetabular cup dia.50mm on the market with this lot#.No other complaints reported on the same lot#.The check of the dhr of the lot# involved (201616072) showed no anomalies on the 49 delta tt acetabular cup dia.54mm on the market with this lot#.No other complaints reported on the same lot#.We will submit a final mdr after completing the investigation on this case.

Event Description

According to the info reported, during two surgeries done on (b)(6) 2017 , respectively, when explanting the existing delta tt cup, one of the bone screws passed through the cup hole, staying in the bone.These bone screws were removed separately after the cup.Surgeon underlined very poor patient bone quality, which is the likely cause of the revisions.Event happened in us.

• Brand Name: DELTA TT ACETABULAR CUP
• Type of Device: DELTA TT ACETABULAR CUP
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale,52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A.; via nazionale,52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer Contact: giulio puppa
• MDR Report Key: 6688962
• MDR Text Key: 79134532
• Report Number: 3008021110-2017-00051
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K112898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial

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: Health Professional
• Device Model Number: 5552.15.540
• Device Lot Number: 201616072
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2017
• 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