MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP; RSP HUM SOCKET INSERT, 32MM, +4MM, STANDARD

Model Number 508-00-432

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Date 09/01/2020

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

Revision surgery - due to stem loosening and possible infection.Removed and exchanged out the stem, head and insert.

Manufacturer Narrative

The reason for this revision surgery was reported as an infection.The previous surgery and the surgery detailed in this event occurred 7 years and 3 months apart.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 the 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 was an ncmr#19864 associated with the main part #508-00-432, rsp hum socket insert, 32mm, +4mm, standard, which documents that out of 40 parts lot, 2 part was rejected due to dimension out of tolerance.Later the rejected parts were found no defect and accepted after proper justification.All other items in the lot were met with the design, fit and function requirements.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 stem loosening and possible infection.There were no findings during this evaluation that indicate the reported devices were the source or had a direct connection with the patient's infection.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.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.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: RSP
• Type of Device: RSP HUM SOCKET INSERT, 32MM, +4MM, STANDARD
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 10600321
• MDR Text Key: 208996811
• Report Number: 1644408-2020-00847
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912024679
• UDI-Public: (01)00888912024679
• Combination Product (y/n): N
• PMA/PMN Number: K100741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

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 Expiration Date: 11/30/2017
• Device Model Number: 508-00-432
• Device Catalogue Number: 508-00-432
• Device Lot Number: 918F1026
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 10/22/2020
• Supplement Dates FDA Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 508-32-101 LOT 862C1236; 510-00-010 LOT 980F1063; 508-32-101 LOT 862C1236; 510-00-010 LOT 980F1063
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR