MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROCOTYL(R) L ACETABULAR CUP; HIP COMPONENT

Model Number PHA0-62XX

Device Problem Unstable (1667)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This complaint will be updated once investigation is complete.Trend will be evaluated.

Event Description

Per article by zajc, et al., ejost.2018 dec.Allegedly, in 2015, a (b)(6) year old male underwent a revision for pain and instability of the right hip.Radiographs revealed decentralization of the femoral head, and the patient was revised.At revision, the polyethylene liner was found broken and the acetabular shell damaged in retroversion.It was impossible to disengage the modular neck form the taper.The following components have no alleged deficiency and were not revised during this surgery: profemur® z-gb mod stem pha00244 lot # ni qty.1 profemur ti mod neck pha01254 lot # ni qty.1.

• Brand Name: PROCOTYL(R) L ACETABULAR CUP
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 8023716
• MDR Text Key: 125638286
• Report Number: 3010536692-2018-01394
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: SI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHA0-62XX
• Device Catalogue Number: PHA0-62XX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/16/2018
• Date Manufacturer Received: 10/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 88