MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION HIP; REVISION HEMISPHERICAL SHELL, MULTI-HOLE, P2 COATED, 54MM

Model Number	400-03-364
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to these documents as soon as it becomes available.
Event or Problem Description
Revision surgery - loosening of cup.
Additional Manufacturer Narrative
Corrected data: see d.1., d2., d.4., d.11.& g.5.Manufacturer narrative: the reason for this revision surgery was reported due to loose cup.The previous surgery and the surgery detailed in this event occurred 2.8 years 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 were 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 loose cup.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 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.

• Brand Name: FOUNDATION HIP
• Common Device Name: REVISION HEMISPHERICAL SHELL, MULTI-HOLE, P2 COATED, 54MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445,
• MDR Report Key: 10276669
• Report Number: 1644408-2020-00575
• Device Sequence Number: 2924116
• Product Code: LPH
• UDI-Device Identifier: 00888912076159
• UDI-Public: (01)00888912076159
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K974093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/17/2023
• Device Model Number: 400-03-364
• Device Catalogue Number: 430-93-054
• Device Lot Number: 043H1021
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 08/19/2020
• 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: 010-55-015 LOT 003A1100; 010-55-015 LOT 003A1100; 010-55-025 LOT 006A1316; 010-55-025 LOT 006A1316; 010-55-040 LOT 010A1079; 010-55-040 LOT 010A1079; 400-03-364 LOT 869B1107; 425-97-009 LOT 174R1088; 934-36-254 LOT 796F1021; 934-36-254 LOT 796F1021; 010-55-015 LOT 003A1100; 010-55-025 LOT 006A1316; 010-55-040 LOT 010A1079; 425-97-009 LOT 174R1088; 934-36-254 LOT 796F1021
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR