MAUDE Adverse Event Report: ENCORE MEDICAL L.P RSP; GLENOID, HEAD W/RETAINING SCREW, RSP, 32MM/-4MM

Model Number 508-32-103

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 09/24/2020

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 - patient had pain.

Manufacturer Narrative

The reason for this revision surgery was reported as pain.The previous surgery and the surgery detailed in this event occurred 30 days 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 the 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 #508-32-103, glenoid, head w/retaining screw, rsp, 32mm/-4mm, which documents that out of 15 parts lot, 1 part was rejected and scrapped due to dimension out of tolerance.All other items 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 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 pain.There were no findings during this evaluation that indicate the reported devices were defective.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 event.Due to short term between previous and revision surgery, it is also possible that event may have occurred due to lack of post-operative care, patient noncompliance with medical instructions or improper surgical technique.There are multiple factors that may also contribute to an event that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant 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: GLENOID, HEAD W/RETAINING SCREW, RSP, 32MM/-4MM
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin,tx 78758-5445
• MDR Report Key: 10719168
• MDR Text Key: 212524943
• Report Number: 1644408-2020-00995
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912024747
• UDI-Public: (01)00888912024747
• 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: 12/30/2020

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 Model Number: 508-32-103
• Device Catalogue Number: 508-32-103
• Device Lot Number: 864C4004
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 12/02/2020
• Supplement Dates FDA Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 509-03-032 LOT 952W1095; 509-03-032 LOT 952W1095
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR