MAUDE Adverse Event Report: LIMACORPORATE SPA DELTA-TT ACETAB.CUP; DELTA-TT ACETAB.CUP (LPH - MBL)

Model Number 5552.15.540

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 04/10/2019

Event Type  Injury  

Manufacturer Narrative

By checking the manufacturing charts of the lot #s involved, no anomalies were found on the overall components placed on the market.This is the first and only complaint on these lot #s.We will submit a final report once the investigation will be concluded.

Event Description

Revision surgery occurred on (b)(6) 2019 due to loosening of acetabular cup.Primary surgery happened on (b)(6) 2015.During revision, the delta-tt acetab.Cup (code #5552.15.540, lot #1104227) and the delta neutr.Liner (code #5885.51.260, lot #1401970) were replaced.The stem, that was manufactured by another company, was also subsided and replaced during revision.The patient was (b)(6) years old.Event occurred in (b)(6).

Manufacturer Narrative

By checking the manufacturing charts of the lot#s involved, no anomalies were found on a total of 10 delta tt acetabular cups manufactured with lot #1104227.This is the first and only complaint received with this lot#.Despite lima's explants request, components involved were disposed of as per hospital policy.No x-rays available to be provided.At this stage, we are not able to perform a deeper investigation of this case.The only conclusion that can be drawn is based on the check of the manufacturing chart and the absence of other similar complaints: with the listed information, we cannot judged this event as product related.Pms data: according to our pms data, we are aware of 8 cases of acetabular cup loosening without infection on more than 73700 delta tt cup code 5552.15.Xxx sold ww since 2007, with a revision rate of 0.011%.No corrective action planned for this specific case.Limacorporate will continue monitoring the market.

Event Description

Hip revision surgery performed on (b)(6) 2019 due to loosening of acetabular cup.Primary surgery was performed on (b)(6) 2015.During revision surgery, delta tt acetabular cup size 54mm (code #5552.15.540, lot #1104227) and the delta neutral liner (code #5885.51.260, lot #1401970) previously implanted were replaced.Acetabular cup implanted during the revision surgery was a delta tt acetabular cup size 56mm.The stem, manufactured by another company, was subsided and also replaced during the revision surgery.The patient is 89 years old.Any other patient's clinical info is unknown.Surgeon happy with the final stability of the implant.Event occurred in australia.

• Brand Name: DELTA-TT ACETAB.CUP
• Type of Device: DELTA-TT ACETAB.CUP (LPH - MBL)
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 8527067
• MDR Text Key: 142352198
• Report Number: 3008021110-2019-00052
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

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: 5552.15.540
• Device Lot Number: 1104227
• Initial Date Manufacturer Received: 04/12/2019
• Initial Date FDA Received: 04/18/2019
• Supplement Dates Manufacturer Received: 04/12/2019
• Supplement Dates FDA Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention