MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP BASEPLATE, 30MM, W/P2 COATING; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 508-32-204

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687); Implant Pain (4561)

Event Date 03/08/2024

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery, the agent reported "(pain / mobility issues presumably due to baseplate position.Baseplate had been placed too superior in primary case.According to revision surgeon doctor socket poly was very worn.Envois baseplate, screws and sphere were.Removed and replaced with tornier.A portion of the envois baseplate central screw broke off in bone and was left in.The patient on purpose.Enovis poly implanted)".The previous surgery and the surgery detailed in this event occurred 4 years and 6 months apart.This evaluation is limited in scope as the items associated with this investigation were not returned to djo surgical - austin for examination.The surgery was completed as intended and without incident.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.There were no findings during this evaluation that indicate the reported devices were defective.The surgeon performed this procedure to remedy the patient's condition.No further action is deemed necessary.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 were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.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 central screw of baseplate broke off, pain and wear.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.There are multiple factors that may also contribute to an event that are outside the control of djo surgical such as poor bone density, prolonged overhead activities, inadequate soft tissue support, patient activities or trauma.

Event Description

Revision surgery - due to pain / mobility issues presumably due to baseplate position.Baseplate had been placed too superior in primary case.According to revision surgeon dr.(b)(6) poly was very worn.Envois baseplate, screws and sphere were.Removed and replaced with tornier.A portion of the envois baseplate central screw broke off in bone and was left in.The patient on purpose.Enovis poly implanted.

Manufacturer Narrative

The agent reported "(pain / mobility issues presumably due to baseplate position.Baseplate had been placed too superior in primary case.According to revision surgeon doctor socket poly was very worn.Envois baseplate, screws and sphere were.Removed and replaced with tornier.A portion of the envois baseplate central screw broke off in bone and was left in.The patient on purpose.Enovis poly implanted)".The previous surgery and the surgery detailed in this event occurred 4 years and 6 months apart.This evaluation is limited in scope as the items associated with this investigation were not returned to djo surgical - austin for examination.The surgery was completed as intended and without incident.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.There were no findings during this evaluation that indicate the reported devices were defective.The surgeon performed this procedure to remedy the patient's condition.No further action is deemed necessary.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 were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.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 central screw of baseplate broke off, pain and wear.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.There are multiple factors that may also contribute to an event that are outside the control of djo surgical such as poor bone density, prolonged overhead activities, inadequate soft tissue support, patient activities or trauma.

• Brand Name: RSP BASEPLATE, 30MM, W/P2 COATING
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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 ; MX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 19056505
• MDR Text Key: 339551278
• Report Number: 1644408-2024-00429
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888912144391
• UDI-Public: 00888912144391
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 508-32-204
• Device Lot Number: 769P1619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/06/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 05/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/29/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 506-03-118 LOT: 832C1575; 506-03-126 LOT: 834C1596; 506-03-130 LOT: 835C1574; 508-32-101 LOT: 862C2895; 509-02-032 LOT: 951W1226
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 135 KG