MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FMP HIP; LINER, ACETABULAR, FMP CONSTRAINED 28XMP5

Model Number 436-28-005

Device Problems Naturally Worn (2988); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Dislocation (2374)

Event Date 02/01/2022

Event Type  Injury  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

Revision surgery - patient dislocated and possible worn liner.

Manufacturer Narrative

The reason for this revision surgery was reported as dislocation.The previous surgery and the surgery detailed in this event occurred 7 months and 1 week apart.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The devices were disposed of at hospital and not made available to djo surgical for examination.A review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There was a nonconformance associated with the main part # 436-28-005, liner, acetabular, fmp constrained 28xmp5 which documents that out of 20 parts lot 1 part was rejected and scrapped.All other items in the lot were met with fit, form and function requirements.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to dislocation.There were no findings during this evaluation that indicate the reported devices were defective.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.There are multiple factors that may also contribute to an event that are outside the control of djo surgical such as poor bone density, inadequate soft tissue support, patient activities or trauma.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: FMP HIP
• Type of Device: LINER, ACETABULAR, FMP CONSTRAINED 28XMP5
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer Contact: kiersten soderman ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 13542109
• MDR Text Key: 285681785
• Report Number: 1644408-2022-00212
• Device Sequence Number: 1
• Product Code: KWZ
• UDI-Device Identifier: 00888912085687
• UDI-Public: (01)00888912085687
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2014
• Device Model Number: 436-28-005
• Device Catalogue Number: 436-28-005
• Device Lot Number: 54039069
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2009
• 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
• Treatment: 436-28-000 LOT 51900L01; 497-28-105 LOT 53842598
• Patient Outcome(s): Required Intervention
• Patient Sex: Female