MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FMP HIP; LINER, ACETABULAR, FMP CONSTRAINED 28XMP7

Model Number	436-28-007
Health Effect - Clinical Code	Skin Discoloration (2074)
Date of Event	07/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Second revision surgery - patient presented with discoloration.She had posterior impingement from the stem.The stem had broken the liner.Surgeon changed the proximal body on the stem (not djo) to have more offset and more head height to relieve impingement.Liner was replaced.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as dislocation.The previous surgery and the revision detailed in this investigation occurred over 2 months and 3 weeks apart.The healthcare professional indicated there was a significant adverse to the patient.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 components used in the previous surgery met design and manufacturing requirements.There was a nonconformance in the main part #436-28-007, liner, acetabular, fmp constrained 28 x mp7, which documents nonconformance that out of (b)(4) was scrapped due to illegible engraving.Remaining (b)(4) met design and manufacturing requirements.The device and its applicable concomitant devices were within their respective expiration dates at the time of use during 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 dislocation.There were no findings during this investigation that indicate that the reported devices were the source or had a direct connection with the patient's event.Agent has clearly mentioned that "patient presented with dislocation.She had posterior impingement from the stem.The stem had broken the liner." it seems that the event might have possibly occurred due to, poor bone density, inadequate soft tissue support, and excessive range of motion, bone impingement, patient activities or trauma.There are many factors that may contribute to the event that are outside the control of djo surgical are poor bone density, inadequate soft tissue support, excessive range of motion, bone impingement, patient activities or trauma.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any patient 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: FMP HIP
• Common Device Name: LINER, ACETABULAR, FMP CONSTRAINED 28XMP7
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 8925929
• Report Number: 1644408-2019-00780
• Device Sequence Number: 16695865
• Product Code: KWZ
• UDI-Device Identifier: 00888912085700
• UDI-Public: (01)00888912085700
• 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: 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): 09/20/2019

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: 06/17/2021
• Device Model Number: 436-28-007
• Device Catalogue Number: 436-28-007
• Device Lot Number: 499C1008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 09/20/2019
• 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: 436-28-000 LOT 496C1077.; 436-28-000 LOT 496C1077
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 69 YR