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

Model Number 508-32-204

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

Patient Problem Failure of Implant (1924)

Event Date 06/02/2021

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 shoulder pain.

Manufacturer Narrative

The reason for this revision surgery was reported as pain.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.This investigation is limited in scope as only partial information was provided to djo surgical.The revised items was not returned for examination and the lot numbers were not provided.To adequately investigate this event, the lot numbers are necessary.Given the limited information, a search for an invoice (of the previous surgery) could not be conducted, therefore; the items removed could not be verified.If this information is submitted at a future date, this investigation will be re-evaluated.Customer complaint history of the reported items showed no present trends or on-going issues that are needing a review.There was no information submitted with this complaint about any patient activities, accidents or medical contraindications that may have contributed to the reported event.The surgeon performed this revision to remedy the patient's condition.This complaint will be closed pending receipt of additional information.No further action is deemed necessary at this time.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
• MDR Report Key: 12063424
• MDR Text Key: 258298071
• Report Number: 1644408-2021-00639
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912144391
• UDI-Public: (01)00888912144391
• Combination Product (y/n): N
• PMA/PMN Number: K112069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

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: 508-32-204
• Device Catalogue Number: 508-32-204
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/24/2021
• Supplement Dates Manufacturer Received: 06/29/2021
• Supplement Dates FDA Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 506-03-122 LOT UNKNOWN; 506-03-130 LOT UNKNOWN; 506-03-134 LOT UNKNOWN; 508-32-103 LOT UNKNOWN; 509-02-032 LOT UNKNOWN; 533-06-108 LOT UNKNOWN; 506-03-122 LOT UNKNOWN; 506-03-130 LOT UNKNOWN; 506-03-134 LOT UNKNOWN; 508-32-103 LOT UNKNOWN; 509-02-032 LOT UNKNOWN; 533-06-108 LOT UNKNOWN
• Patient Outcome(s): Required Intervention