MAUDE Adverse Event Report: ENCORE MEDICAL L. P. FMP HIP; LINER, ACETABULAR, FMP CONSTRAINED 28XMP9

Model Number 436-28-000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 10/23/2020

Event Type  Injury  

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 - due to patient broke previous construct liner so dr.(b)(6) replaced the components.

Event Description

Revision surgery - due to patient broke previous construct liner so surgeon replaced the components.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery was reported as broken construct liner.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 that 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.This investigation is limited in scope as only partial information was provided to djo surgical for review.The revised items were not returned for examination and the item and or lot numbers were not provided.To adequately investigate this event, the part and or lot number is necessary.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.The root cause of this complaint was reported as broken construct liner.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.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery was reported as broken construct liner.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 that 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.This investigation is limited in scope as only partial information was provided to djo surgical for review.The revised items were not returned for examination and the lot numbers were not provided.To adequately investigate this event, the lot numbers are necessary.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.Given the limited information, a search for an invoice (of the previous surgery) could not be conducted, therefore; the items removed could not be identified.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.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: FMP HIP
• Type of Device: LINER, ACETABULAR, FMP CONSTRAINED 28XMP9
• Manufacturer (Section D): ENCORE MEDICAL L. P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 10881691
• MDR Text Key: 217638084
• Report Number: 1644408-2020-01127
• Device Sequence Number: 1
• Product Code: KWZ
• UDI-Device Identifier: 00888912085663
• UDI-Public: (01)00888912085663
• Combination Product (y/n): N
• PMA/PMN Number: K023794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 436-28-000
• Device Catalogue Number: 436-28-009
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 436-28-000 LOT UNKNOWN.; 436-28-009, LOT UNKNOWN.; 497-28-105 LOT UNKNOWN.; 497-28-105, LOT UNKNOWN.
• Patient Outcome(s): Required Intervention