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

Model Number 508-32-101

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2020

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

Second revision surgery - due to dislocation.

Manufacturer Narrative

Additional narrative: see d10 - concomitant medical products 508-32-204 lot 769p1787 was not reported on 1644408-2020-00738_fu1.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery was reported as dislocation.The previous surgery and the surgery detailed in this event occurred 22 days apart.The in vivo time for the remainder of the items is 22 and 54 days, from the primary and previous revision surgery.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 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 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 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.

• Brand Name: RSP
• 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: 10482767
• MDR Text Key: 205311167
• Report Number: 1644408-2020-00738
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912024730
• UDI-Public: (01)00888912024730
• 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,Followup
• Report Date: 12/01/2020

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: 508-32-101
• Device Catalogue Number: 508-32-101
• Device Lot Number: 862C3134
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 09/23/2020; 10/21/2020
• Supplement Dates FDA Received: 10/21/2020; 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 506-03-114 LOT 831C1790; 506-03-114 LOT 831C1790; 506-03-114 LOT 831C1794; 506-03-130 LOT 835C1650; 506-03-130 LOT 835C1669; 508-32-204 LOT 769P1787; 508-32-204, LOT 769P1787; 509-00-432 LOT 954W1055; 509-03-432 LOT 954W1055; 508-32-204 LOT 769P1787; 509-00-432 LOT 954W1055
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR