MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FMP HIP; LINER, LOCKING RING, CONSTRAINED

Model Number	436-28-000
Health Effect - Clinical Code	Fall (1848)
Date of Event	06/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was reported as damaged liner after a fall.The previous surgery and the surgery detailed in this event occurred 15 days apart.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 device was disposed of at hospital and not made available to djo surgical for examination.A review of the device history record (dhr) shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There was no non-conforming material report (ncmr) associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.Customer.Complaint history of the reported device 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 damaged liner after a fall.There were no findings during this evaluation that indicate the reported device was defective.The surgeon performed this procedure to remedy the patient's condition.No further action is deemed necessary.No other information was submitted with the complaint regarding pre-existing conditions of the patientor any activities the patient was involved in that may have contributed to the event.Agent has clearly mentioned that "patient fell" and also due to short time between previous and revision surgery, it is possible that the event may have occurred due to lackof post-operative care, patient noncompliance with medical instructions, improper surgical technique, patient activities or trauma.There are multiple factors that may also 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.
Event or Problem Description
Revision surgery - patient fell and constrained liner was damaged replaced locking ring.

• Brand Name: FMP HIP
• Common Device Name: LINER, LOCKING RING, CONSTRAINED
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 12088861
• Report Number: 1644408-2021-00656
• Device Sequence Number: 17137610
• 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 Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2021

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: 436-28-000
• Device Lot Number: 496C1091
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2021
• Initial Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR