MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP; BASEPLATE, GLENOID HA-COAT, RSP, 6.5MM X 30MM

Model Number 508-32-104

Device Problems Break (1069); Crack (1135)

Patient Problem Pain (1994)

Event Date 08/10/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Complaint - seven months after the primary surgery (reverse), the patient complained of pain after she heard a cracking sound (cracking joints) inside her body.And x-ray confirmed that the baseplate center screw was broken.Revised(after existing implants removed).

Event Description

Revision surgery - seven months after the primary surgery (reverse) the patient complained of pain, after she heard a cracking sound (cracking joints) inside her body.X-ray confirmed that baseplate center screw was broken.Revised (after existing implants removed).

Manufacturer Narrative

Corrected data: manufacturer narrative: the reason for this revision surgery was reported as pain and baseplate center screw was broken.The previous surgery and the surgery detailed in this event occurred 6 months and 2 weeks apart.Initial or prolonged hospitalization was required.The healthcare professional indicated there was a significant adverse event to the patient.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 ncmr#40071 associated with the main part #508-32-104, baseplate, glenoid ha-coat, rsp, 6.5mm x 30mm, which documents that out of 40 parts lot, 1 part was rejected and scrapped (voided).All other items in the lot were met with the design, fit 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 reported as pain and baseplate center screw was broken.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, patient bone deterioration, 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 as soon as it becomes available.

• Brand Name: RSP
• Type of Device: BASEPLATE, GLENOID HA-COAT, RSP, 6.5MM X 30MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 10913772
• MDR Text Key: 218510582
• Report Number: 1644408-2020-01119
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912024754
• UDI-Public: (01)00888912024754
• Combination Product (y/n): N
• PMA/PMN Number: K051075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2023
• Device Model Number: 508-32-104
• Device Catalogue Number: 508-32-104
• Device Lot Number: 866C2379
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 508-32-103 LOT 864C2869; UNK-SURG LOT UNKNOWN; UNK-SURG LOT UNKNOWN; UNK-SURG LOT UNKNOWN
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 84 YR