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

Model Number	931-36-750
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	06/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - patient fell and fractured her leg.
Additional Manufacturer Narrative
Corrected data: see also d.1, d.2., d.4., d.11 and g.5.Manufacturer narrative: the reason for this revision surgery was due to fracture.The previous surgery and the revision detailed in this investigation occurred over 17 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 the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhr), shows that the reported component(s) used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) 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 devices showed no present trends or on- going issues that are in need of review.The root cause of this complaint was a revision surgery due to fracture.There were no findings during this investigation that indicate that the reported devices was the source or had a direct connection with the patient's event.Agent has clearly mentioned that "patient fell and fractured her leg", it seems that the event may have possibly occurred due to: lack of post-operative care, patient noncompliance with medical instructions, patient activities or trauma.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any activities that may have contributed to the event and hence a definitive root cause cannot be determined.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: TAPERFILL HIP
• Common Device Name: TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 10
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8791265
• Report Number: 1644408-2019-00648
• Device Sequence Number: 1891359
• Product Code: LPH
• UDI-Device Identifier: 00190446177913
• UDI-Public: (01)00190446177913
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2019

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: 05/06/2025
• Device Model Number: 931-36-750
• Device Catalogue Number: 425-97-010
• Device Lot Number: 175R2095
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 09/13/2019
• 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: 400-03-362 LOT 866B1517.; 400-03-362 LOT 866B1517.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR