MAUDE Adverse Event Report: ENCORE MEDICAL L.P SOCKET, INSERT 32MM SEMI RSP HUMERAL; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	508-01-032
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery, the agent reported "(revision due to post-op infection.No implant failure.All prior implants removed)." the previous surgery and the surgery detailed in this event occurred 23 days apart.This evaluation is limited in scope as limited information was provided to djo surgical - (b)(4) for examination.If information regarding cultures identified in the infection, the severity of the infection or any other relevant information is submitted at a future date, this investigation will be re-evaluated.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.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.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 a nonconformance associated with the main part #508-01-032, socket, insert 32mm semi rsp humeral, which documents that out of(b)(4) was rejected and scrapped due to dimension out of tolerance.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 an 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 the control of djo surgical.
Event or Problem Description
Revision surgery - due to infection.

• Brand Name: SOCKET, INSERT 32MM SEMI RSP HUMERAL
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 16812032
• Report Number: 1644408-2023-00505
• Device Sequence Number: 12183290
• Product Code: PHX
• UDI-Device Identifier: 00888912024693
• UDI-Public: 00888912024693
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K051075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2023

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: 05/04/2025
• Device Model Number: 508-01-032
• Device Catalogue Number: 508-01-032
• Device Lot Number: 859C1161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 506-03-114 LOT: 831C2223; 506-03-118 LOT: 832C1978; 506-03-118 LOT: 832C2039; 506-03-122 LOT: 833C1878; 508-32-103 LOT: 864C5730; 508-32-104 LOT: 866C3089; 510-00-006 LOT: 977F1171
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female