MAUDE Adverse Event Report: ENCORE MEDICAL L.P. LIMA HIP; REV DISTAL STM, 14X200MM

Model Number	428-14-200
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was reported as stem subsided.The previous surgery and the surgery detailed in this event occurred 4 years and 3 months 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 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 was an ncmr#(b)(4), associated with the main part 428-14-200, rev distal stm, 14x 200mm, which documents that out of (b)(4) parts lot (b)(4) parts were rejected due to parts didn't go through the gauge for size verification.Later the rejected parts were reworked and accepted proper justification.All other parts in the lot met with fit, form and function requirements.The devices were verified to have gone through an acceptable sterilization process and were 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 stem subsided.There were no findings during this evaluation that indicate the reported devices were defective.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 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 - the stem subsided which left the patient short.Stem, body, head and liner were all remove and exchanged.Cup stayed and we used for the exchange of the liner and the rest of the implants were replaced.

• Brand Name: LIMA HIP
• Common Device Name: REV DISTAL STM, 14X200MM
• 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: 13338215
• Report Number: 1644408-2022-00082
• Device Sequence Number: 4064587
• Product Code: KWA
• UDI-Device Identifier: 00888912081443
• UDI-Public: (01)00888912081443
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/24/2022

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 Expiration Date: 02/28/2019
• Device Model Number: 428-14-200
• Device Catalogue Number: 428-14-200
• Device Lot Number: 1213408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 400-03-442 LOT 877B1021; 428-01-070 LOT 1514921; 931-44-760 LOT 764N1925
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male