MAUDE Adverse Event Report: ENCORE MEDICAL L.P LINEAR HIP; STEM, HIP, FEMORAL, LINEAR SIZE12 LATERAL (SPCL ORDER) R-NECK

Model Number	932-44-760
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	06/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - patient had fallen off his bike and had a periprosthetic fracture.Removed everything except the cup and screws.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as peri-prosthetic fracture.The previous surgery and the revision detailed in this investigation occurred over 5 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 device was disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhrs) show that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the event.The device and its applicable concomitant devices were within their respective expiration date at the time of use during the previous surgery.Customer complaint history of the reported device 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 peri-prosthetic fracture.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the patient's event.Agent has clearly mentioned that patient fell and sustained a peri-prosthetic fracture, it seems that the event may have occurred due to excessive loading, poor bone density, lack of care, patient activities or trauma.No additional information was submitted with the complaint regarding pre-existing conditions of the patient 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: LINEAR HIP
• Common Device Name: STEM, HIP, FEMORAL, LINEAR SIZE12 LATERAL (SPCL ORDER) R-NECK
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd.; 9800 metric blvd; austin,tx 78758-5445
• MDR Report Key: 8768376
• Report Number: 1644408-2019-00643
• Device Sequence Number: 16199743
• Product Code: LPH
• UDI-Device Identifier: 00888912100472
• UDI-Public: (01)00888912100472
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K991325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 07/31/2019

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: 08/31/2019
• Device Model Number: 932-44-760
• Device Catalogue Number: 425-11-012
• Device Lot Number: 113C1040
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 07/08/2019
• Supplement Report FDA Received Date: 08/06/2019
• 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: 400-03-442 LOT 877B1013; 400-03-442 LOT 877B1013; 425-11-012 LOT 113C1040; 932-44-760 LOT 816N1001; 400-03-442 LOT 877B1013; 425-11-012 LOT 113C1040
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR