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	08/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Expiration date: 06/08/27.Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Complaint - when representative opened implant box the item did not match.Should have been item 509-01-032 however in the box was a patella implant rep mentioned did not know reference number for the patella item surgeon opened a rsp semi constrained poly and there was a patella poly inside of it.
Additional Manufacturer Narrative
The reason for this complaint was reported as mislabeling of an item.The healthcare professional indicated that the event occurred during surgery, near the patient.There was no risk or adverse event reported by the surgeon.There was a five (5) minute delay in surgery but the surgery was completed as intended.The agent was present when the event occurred and was able to provide another suitable device.A review of the device history records (dhr) wo# (b)(4) and wo# (b)(4) 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 and 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.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.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• 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: 15314956
• Report Number: 1644408-2022-01115
• Device Sequence Number: 6360954
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2022

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female