MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP; RSP BASEPLATE, 30MM, W/P2 COATING

Model Number 508-32-204

Device Problem Use of Device Problem (1670)

Patient Problem Failure of Implant (1924)

Event Date 02/07/2022

Event Type  Injury  

Event Description

Revision surgery: patient experienced shoulder instability after receiving a reverse total shoulder replacement.Instability was due to improper placement of the glenohumeral baseplate which provided instability of the shoulder capsule after the djo glenosphere and reverse stem/shell were implanted.At the time of surgery shoulder must have appeared to be stable as surgeon proceeded to close and apparently patient presented post-operation with unstable shoulder joint.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Revision surgery: patient experienced shoulder instability after receiving a reverse total shoulder replacement.Instability was due to improper placement of the glenohumeral baseplate which provided instability of the shoulder capsule after the djo glenosphere and reverse stem/shell were implanted.At the time of surgery shoulder must have appeared to be stable as surgeon proceeded to close and apparently patient presented post-operation with unstable shoulder joint.

Manufacturer Narrative

The reason for this revision surgery was reported as instability.The actual length of in-vivo for the items listed is unknown as the original surgery date was not provided or could be established.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 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 is 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 becoming unstable.The findings did not lead to a firm conclusion since the needed records were not made available at the time of this investigation.If more information is received later, the complaint will be updated.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 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: RSP BASEPLATE, 30MM, W/P2 COATING
• 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: kiersten soderman ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 13577308
• MDR Text Key: 285934325
• Report Number: 1644408-2022-00242
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912144391
• UDI-Public: (01)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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 508-32-204
• Device Catalogue Number: 508-32-204
• Device Lot Number: 769P2233
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2021
• 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: 508-32-103 LOT 864C4905; 509-03-032 LOT 952W1168; UNK-SURG LOT UNKNOWN; UNK-SURG LOT UNKNOWN; UNK-SURG LOT UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male