MAUDE Adverse Event Report: ENCORE MEDICAL L.P. TAPERFILL HIP; TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 10

Model Number 425-97-010

Device Problems Loose or Intermittent Connection (1371); Unintended Movement (3026)

Patient Problem Fall (1848)

Event Date 01/22/2020

Event Type  Injury  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to these documents as soon as it becomes available.

Event Description

Revision surgery - the patient had a fall after surgery, which caused the implant to subside.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery was reported as fall.The previous surgery and the surgery detailed in this event occurred 22 days apart.Initial or prolonged hospitalization was required.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) shows that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There was no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.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 fall.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.Due to the short time between previous and revision surgery and also the agent has clearly mentioned that "the patient had a fall after surgery, this caused the implant to subside".It is also possible that the event may have been occurred due to lack of post-operative care, patient noncompliance with medical instructions, incorrect implant selection.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: TAPERFILL HIP
• Type of Device: TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 10
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445,
• MDR Report Key: 9733277
• MDR Text Key: 180347717
• Report Number: 1644408-2020-00109
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00888912078689
• UDI-Public: (01)00888912078689
• Combination Product (y/n): N
• PMA/PMN Number: K130099
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/18/2020

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: 425-97-010
• Device Catalogue Number: 425-97-010
• Device Lot Number: 175R2126
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2020
• Initial Date FDA Received: 02/20/2020
• Supplement Dates Manufacturer Received: 02/21/2020
• Supplement Dates FDA Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 400-03-362 LOT 866B1584
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 94 YR
• Patient Weight: 77