MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. RSP; RSP HUM SOCKET INSERT, 44M +4MM, SEMI

Model Number	508-01-444
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this second revision surgery was due to an infection.The previous revision surgery and the surgery detailed in this investigation occurred 2.5 years apart.With the exception of the insert and head, the remainder of the items were in vivo for 3.0 years from the original surgery.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 a serious risk 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 (dhrs) show that the reported components 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.The root cause of this complaint was reported as an infection.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the patient's infection.There are multiple factors that may contribute to an infection that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.
Event or Problem Description
Second revision surgery - patient is 2.5 years post-operation and presented with possible infection.Surgeon opted to revise and remove all existing implants.

• Brand Name: RSP
• Common Device Name: RSP HUM SOCKET INSERT, 44M +4MM, SEMI
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin texas 78758
• MDR Report Key: 8804790
• Report Number: 1644408-2019-00671
• Device Sequence Number: 343146
• Product Code: PHX
• UDI-Device Identifier: 00888912144315
• UDI-Public: (01)00888912144315
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 508-01-444
• Device Catalogue Number: 508-01-444
• Device Lot Number: 925F1004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 506-03-114 LOT 831C1306; 506-03-122 LOT 833C1240; 506-03-130 LOT 835C1254; 506-03-134 LOT 836C1117; 508-32-104 LOT 866C2103; 508-44-101 LOT 877C1032; 530-08-108 LOT 406T1034
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 100