MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP; RSP SEMICONSTRAINED HUMERAL SOCKET INSERT, 32MM, HXE-PLUS

Model Number	509-01-032
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Expiration date : 06/08/27 (08-june-2027).The reason for this complaint was reported as mislabeling or incorrect marking.The healthcare professional indicated this event occurred during surgery, away from the patient.There was no risk or adverse event reported by the surgeon.There was no delay in surgery and the surgery was completed as intended.The devices were returned to manufacturer and evaluated by registered medical assistant (rma) at djo surgical.A review of the device history records (dhr) wo#a13458227 130-03-738 and wo#a13469997 509-01-032 indicates that both lots were for 17 pieces.Both work orders were processed by the same operator through flow bench verification and tray kit assembly.Both work orders were processed by the same operator through seal - tray assembly.The labels on the bottom of the tray, petg, and outer packaging all match.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.A review of the complaint databased identified for the same lots and for the same alleged issue.This complaint is also linked to hhe-2022-00008.The root cause of this complaint is likely due to the parts were swapped between the part verification/tray kitting and the tray seal operation.Rma examination: the reported device was returned to djo surgical for evaluation.There was a domed tri-peg patella within the humeral socket insert packaging.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Complaint - surgeon opened a sealed shoulder liner box and there was a patella inside.

• Brand Name: RSP
• Common Device Name: RSP SEMICONSTRAINED HUMERAL SOCKET INSERT, 32MM, HXE-PLUS
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 15303758
• Report Number: 1644408-2022-01101
• Device Sequence Number: 5339067
• Product Code: PHX
• UDI-Device Identifier: 00888912144612
• UDI-Public: (01)00888912144612
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 08/26/2022

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 Model Number: 509-01-032
• Device Catalogue Number: 509-01-032
• Device Lot Number: 381P1167
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2022
• 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: 130-03-738 LOT 157N1556
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown