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

Model Number 508-00-032

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 09/22/2020

Event Type  Injury  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Event Description

Revision surgery - due to subluxation of humerus.

Manufacturer Narrative

The reason for this revision surgery was reported as subluxation of humerus.The previous surgery and the surgery detailed in this event occurred 5 years and 10 months apart.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 devices were disposed of at hospital and not made available to djo surgical for examination.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 #508-00-032, socket, insert 32mm std.Rsp humeral which documents that out of 40 parts lot, 2 part were rejected and scraped due to tool marks on the part.All other item in the lot were met with the design, fit and function requirements.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 device 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 subluxation.There were no findings during the evaluation that indicate the reported devices were defective.No other 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 event.There are multiple factors that may contribute to an event that are outside the control of djo surgical such as poor bone density, patient bone deterioration, inadequate soft tissue support, prolonged overhead activities, patient activities or trauma.There are no indications of a product or process issue affecting implants safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: RSP
• Type of Device: SOCKET, INSERT 32MM STD. RSP HUMERAL
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 10704756
• MDR Text Key: 212099223
• Report Number: 1644408-2020-00940
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912024648
• UDI-Public: (01)00888912024648
• Combination Product (y/n): N
• PMA/PMN Number: K051075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 508-00-032
• Device Catalogue Number: 508-00-032
• Device Lot Number: 855C1900
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 11/02/2020
• Supplement Dates FDA Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 508-00-000 LOT 848C1479; 508-32-101 LOT 862C1446; 508-00-000 LOT 848C1479; 508-32-101 LOT 862C1446
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR