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

Model Number 508-32-204

Device Problem Defective Component (2292)

Patient Problem No Information (3190)

Event Date 09/04/2018

Event Type  Injury  

Event Description

Revision surgery - due to baseplate component failure being present with glenoid implants.

Event Description

Revision surgery - due to baseplate component failure (central screw broke) being present with glenoid implants.

Manufacturer Narrative

The reason for this revision surgery was due to component failure.The previous revision surgery and the revision surgery detailed in this investigation occurred 9.9 months apart.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.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 device was disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhr), shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of use during the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to component failure.There were no findings during this investigation that indicate that the reported device was defective.A follow up email clarified that "baseplate component failure" meant the central screw was broken.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

Manufacturer Narrative

The reason for this revision surgery was due to component failure.The previous revision surgery and the revision surgery detailed in this investigation occurred 9.9 months apart.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.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 device was disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhr), shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of use during the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to component failure.There were no findings during this investigation that indicate that the reported device was defective.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

Manufacturer Narrative

The reason for this revision surgery was due to component failure.The previous revision surgery and the revision surgery detailed in this investigation occurred 9.9 months apart.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.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 device was disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhr), shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of use during the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to component failure.There were no findings during this investigation that indicate that the reported device was defective.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: RSP SHOULDER
• Type of Device: RSP BASEPLATE, 30MM, W/P2 COATING
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7877520
• MDR Text Key: 120300441
• Report Number: 1644408-2018-00860
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888912144391
• UDI-Public: (01)00888912144391
• Combination Product (y/n): N
• PMA/PMN Number: K112069
• 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: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2023
• Device Model Number: 508-32-204
• Device Catalogue Number: 508-32-204
• Device Lot Number: 769P1313
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 506-03-118, LOT 832C1339; 506-03-118, LOT 832C1339; 506-03-118, LOT 832C1362; 506-03-118, LOT 832C1362; 506-03-122, LOT 833C1352; 508-00-436, LOT 919F1908; 508-00-436, LOT 919F1908; 508-36-101, LOT 869C2291; 508-36-101, LOT 869C2291; 506-03-118, LOT 832C1339; 506-03-118, LOT 832C1362; 508-00-436, LOT 919F1908; 508-36-101, LOT 869C2291
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 73 YR