MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP; RSP BASEPLATE, 30MM, W/P2 COATING

Model Number 508-32-204

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 05/11/2020

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was reported due to not having adequate fixation on the glenoid.The previous surgery and the surgery detailed in this event occurred 1.3 years apart.Initial and prolonged hospitalization was required.The healthcare professional indicated that 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 were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.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 not having adequate fixation on the glenoid.There were no findings during this evaluation that indicate that the reported devices were defective.No other 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 contribute to an event that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.

Event Description

Revision surgery - ultimately, the baseplate and all implants associated with it did not have adequate fixation on the glenoid, causing pain and limited mobility for the patient.They were all removed, along with the insert and +8mm spacer, the latter of which to aid in the removal of the baseplate components.Since there was not adequate bone stock left in the glenoid, doctor opted to convert to a hemi-arthroplasty to allow the glenoid to heal as much as possible for a possible future revision conversion back to reverse.

• Brand Name: RSP
• Type of Device: RSP BASEPLATE, 30MM, W/P2 COATING
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx
• Manufacturer Contact: teffany hutto ; 9800 metric blvd; austin, tx
• MDR Report Key: 10128753
• MDR Text Key: 194781054
• Report Number: 1644408-2020-00436
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912144391
• UDI-Public: (01)00888912144391
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112069
• 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
• Report Date: 06/04/2020

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: Health Professional
• Device Model Number: 508-32-204
• Device Catalogue Number: 508-32-204
• Device Lot Number: 769P1508
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2020
• Initial Date FDA Received: 06/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2018
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 75 YR