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

Model Number	436-28-000
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - due to patient broke previous construct liner so dr.(b)(6) replaced the components.
Event or Problem Description
Revision surgery - due to patient broke previous construct liner so surgeon replaced the components.
Additional 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.
Additional 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
• Common Device Name: LINER, ACETABULAR, FMP CONSTRAINED 28XMP9
• Manufacturer (Section D): ENCORE MEDICAL L. P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 10881691
• Report Number: 1644408-2020-01127
• Device Sequence Number: 11527124
• Product Code: KWZ
• UDI-Device Identifier: 00888912085663
• UDI-Public: (01)00888912085663
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K023794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2021

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
• Operator of Device: Health Professional
• Device Model Number: 436-28-000
• Device Catalogue Number: 436-28-009
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 02/18/2021; 04/05/2021
• Initial Report FDA Received Date: 11/22/2020
• Supplement Report FDA Received Date: 03/18/2021; 07/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 436-28-000 LOT UNKNOWN.; 436-28-009, LOT UNKNOWN.; 497-28-105 LOT UNKNOWN.; 497-28-105, LOT UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention