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

Model Number 508-32-104

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 09/08/2018

Event Type  Injury  

Event Description

Revision surgery - due to the patient having an infection.The surgeon removed all implants and another vendor was used.

Manufacturer Narrative

The reason for this revision surgery was reported as an infection.The previous surgery and the revision detailed in this investigation occurred 2.2 years apart.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 infection or inhibited the patient's immune system.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 device was disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhrs) show that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to an infection.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The device was verified to have gone through an acceptable sterilization process and was within it's expiration date at the time of use during the previous surgery.There were no findings during this investigation that indicate that the reported device was the root cause or had a direct connection with the patient's infection.There are multiple factors that may contribute to an infection that are outside of the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: RSP SHOULDER
• 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: 7919206
• MDR Text Key: 122073777
• Report Number: 1644408-2018-00918
• 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: 10/12/2018

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: 04/20/2022
• Device Model Number: 508-32-104
• Device Catalogue Number: 508-32-104
• Device Lot Number: 866C2109
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2018
• Initial Date FDA Received: 09/28/2018
• Supplement Dates Manufacturer Received: 10/12/2018
• Supplement Dates FDA Received: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 506-03-114, LOT 831C1318; 506-03-114, LOT 831C1318; 506-03-134, LOT 836C1109; 506-03-134, LOT 836C1121; 508-32-101, LOT 862C2178; 509-00-032, LOT 377P1096; 510-08-000, LOT 142G1155; 530-12-108, LOT 412T1042; 506-03-114, LOT 831C1318; 506-03-114, LOT 831C1318; 506-03-134, LOT 836C1109; 506-03-134, LOT 836C1121; 508-32-101, LOT 862C2178; 509-00-032, LOT 377P1096; 510-08-000, LOT 142G1155; 530-12-108, LOT 412T1042
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR