MAUDE Adverse Event Report: ENCORE MEDICAL L.P. REVERSE SHOULDER PROSTHESIS; GLENOID, HEAD W/RETAINING SCREW, RSP, 32MM/NEUTRAL

Model Number 508-32-104

Device Problem Disconnection (1171)

Patient Problem No Code Available (3191)

Event Date 07/23/2018

Event Type  Injury  

Event Description

Revision surgery - due to disassociation of glenosphere from baseplate.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery was reported as disassociation of glenosphere from baseplate.The previous surgery and the surgery detailed in this event occurred 2 months and 21 days apart.The healthcare professional indicated there was a significant adverse event.There was no delay in surgery and another suitable device was available for use.There are no indications that the patient failed to follow surgeon's post-op advice and there is no evidence of trauma reported by the surgeon.Review of complaint and 0400-0145, rsp ifu, does not indicate there were any contraindications for this surgery.The revision surgery was completed as intended.The device was returned to djo surgical.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 for rsp head/baseplate dissociation was reviewed.48 occurrences of dissociation have occurred.Sales history of the rsp baseplates indicates a total of 48,264 baseplates sold to date.This represents an occurrence rate of 0.10% for all causes.No indication of a negative product performance trend was identified.The root cause of this event was dissociation for unknown reason.Factors that could have contributed to this revision include improper part alignment, bone or soft tissue impingement, failure to follow surgical technique or debris in taper during assembly.Patient issues such as trauma, or use of a wheelchair or walker could also contribute to this failure mode.No information was submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.Should additional information become available this investigation will be re-opened for further evaluation.

• Brand Name: REVERSE SHOULDER PROSTHESIS
• Type of Device: GLENOID, HEAD W/RETAINING SCREW, RSP, 32MM/NEUTRAL
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7770267
• MDR Text Key: 116699001
• Report Number: 1644408-2018-00767
• 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: 11/06/2019

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 Expiration Date: 02/07/2024
• Device Model Number: 508-32-104
• Device Catalogue Number: 508-32-101
• Device Lot Number: 862C2563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 09/30/2019
• Supplement Dates FDA Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 506-03-118, LOT 832C1420; 506-03-118, LOT 832C1420; 506-03-138, LOT 837C1108; 506-03-138, LOT 837C1108; 506-03-138, LOT 837C1115; 506-03-138, LOT 837C1115; 508-00-032, LOT 855C2167; 508-00-032, LOT 855C2167; 508-32-104, LOT 866C2426
• Patient Outcome(s): Required Intervention