MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. RIM-LOCK BIOLOX DELTA CERAMIC LINER; HIP COMPONENT

Model Number PHA04510

Device Problems Failure to Align (2522); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event Description

Allegedly, patient was revised due to malalignment ? stem|malalignment? socket|unexplained pain.Revision njr number: (b)(6).Side: l.Primary asa: p2 - mild disease not incapacitating.Components not revised: phac1214 profemur® neck a/r var/val 2 long cobalt chrome, lot#1683882, qty:1.Pha05512 profemur® l hip stem size 6 ha coated, lot#1712402, qty:1.

• Brand Name: RIM-LOCK BIOLOX DELTA CERAMIC LINER
• 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: 13009289
• MDR Text Key: 282260588
• Report Number: 3010536692-2021-00585
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

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: Other
• Device Model Number: PHA04510
• Device Catalogue Number: PHA04510
• Device Lot Number: 1703647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/25/2021
• Initial Date Manufacturer Received: 11/25/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 11/25/2021
• Supplement Dates FDA Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention