MAUDE Adverse Event Report: ENCORE MEDICAL L. P. FMP EXTENDED LINERS; LINER/NON-HOODED-NEU, MP6, HXE-PLUS, 36MM

Model Number	931-36-750
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was due to an infection.The previous surgery and the surgery detailed in this event occurred 12 days apart.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The healthcare professional indicated there was no delay in surgery and another suitable device was available.The revision surgery was completed as intended and without incident.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history record show that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.Nonconforming material report history below.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.Ncmr# 53651 item: 931-36-750 lot 010v1152 lot quantity-10, sample quantity-0, reject quantity-10, failure code-o13 - gas plasma sterilization failed, cause code-eq01 - machine, revision found-a, defect description- power failure during sterility run e191220o causing gas plasma sterilization to fail, specification requirements-.2000.2140 cycle must be completed and pass, disposition-rework, justification- see attached rework steps to re-sterilize parts.Parts will not be eligible for further re-sterilization after rework is completed.Customer complaint history of the reported device showed no present trends or on-going issues that are needing a review.The root cause of this complaint was reported as an infection.There were no findings during this evaluation that indicate that the reported device was 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 possible infection or inhibited the patient's immune system.Due to the short time between the original surgery and the revision, it is possible that the infection was acquired in the hospital (nosocomial).It is also possible that the patient was not compliant with post-surgical instructions.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.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Revision surgery - due to infection.

• Brand Name: FMP EXTENDED LINERS
• Common Device Name: LINER/NON-HOODED-NEU, MP6, HXE-PLUS, 36MM
• Manufacturer (Section D): ENCORE MEDICAL L. P.; 9800 metric blvd; austin, tx
• MDR Report Key: 10480097
• Report Number: 1644408-2020-00754
• Device Sequence Number: 2795620
• Product Code: OQG
• UDI-Device Identifier: 00190446177913
• UDI-Public: (01)00190446177913
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/19/2024
• Device Model Number: 931-36-750
• Device Catalogue Number: 931-36-750
• Device Lot Number: 010V1152
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR