MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; SOCKET, INSERT 32MM SEMI RSP HUMERAL

Catalog Number	508-01-032
Health Effect - Clinical Codes	Fall (1848); Joint Dislocation (2374)
Date of Event	03/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Corrected data: original initial report was submitted as follow up in error.
Event or Problem Description
Revision surgery - due to the patient presenting at emergency room with a dislocated shoulder after a fall.
Additional Manufacturer Narrative
The reason for this revision surgery was the patient's shoulder dislocated.The patient implant was in-vivo for 8.7 years.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 device was disposed of at the hospital and not made available to djo surgical forexamination.A review of the device history records (dhrs) showed no non-conforming material reports (ncmrs) associated with the main contributor component listed in the complaint.All parts met design and manufacturing specifications.The product complaint report (pcr) history was reviewed and no trends or on-going issues were deemed as present or in need of review.This event is deemed as non-product related.The root cause of the shoulder dislocation was reported as a fall.The surgeonreported no issues associated with the explanted product.

• Brand Name: DJO SURGICAL
• Common Device Name: SOCKET, INSERT 32MM SEMI RSP HUMERAL
• 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: stacey bonnell ; 9800 metric blvd.; austin, TX 78758
• MDR Report Key: 10542701
• Report Number: 1644408-2016-00256
• Device Sequence Number: 3161935
• Product Code: KWS
• UDI-Device Identifier: 00888912024693
• UDI-Public: 00888912024693
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K051075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: 12/31/2010
• Device Catalogue Number: 508-01-032
• Device Lot Number: 600992
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/25/2016
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2006
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female