MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL Ø60 TWO-HOLES

Catalog Number 01.32.160DH

Device Problems Device Slipped (1584); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 04/03/2017

Event Type  Injury  

Manufacturer Narrative

Additional information received on 10 april 2017 and includes: there was added surgery time, 15 minutes, because the surgeon had to use the reamer again to go up to size 62 cup.Not yet received.

Event Description

During the surgery, performed posteriorly, the surgeon used a trial cup and decided on a 60 mpact cup.He was happy it was secure.He then used a trial liner and continued onto the femur.He trialled with a size 3 stem and 36mm head and was happy with his offset.The surgeon then implanted the definitive liner (36g) and the stem.He trialled one more time with the 36mm head and when he dislocated he realised the cup was loose.He wasn't sure why it was loose.He trialled a cup again but it wouldn't sit well.He was then forced to ream up to a 62 and then the trial 62 fit better.He then asked to open a 62 cup and 36g hooded liner which were implanted successfully.The surgeon was unsure of why it didn't stay implanted and couldn't see anything wrong within the patient.He used 2 screws (25mm, 20mm) in the new cup as extra security.

Manufacturer Narrative

On 18 may 2017 the r&d project manager performed a visual inspection of the retrieved items and commented as follows: the pieces were analyzed.The cup was assembled together with the hooded pe liner and the pieces did not show any particular sign.From the received pieces it was not possible to determine the root cause of the event.

• Brand Name: MPACT ACETABULAR SHELL Ø60 TWO-HOLES
• Type of Device: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6540338
• MDR Text Key: 74303644
• Report Number: 3005180920-2017-00229
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K132879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2021
• Device Catalogue Number: 01.32.160DH
• Device Lot Number: 161861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/03/2017
• Initial Date FDA Received: 05/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2016
• 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): Other
• Patient Age: 54 YR