MAUDE Adverse Event Report: ENCORE MEDICAL L. P. FOUNDATION POROUS COATED HIP; FMP HEMISPHERICAL SHELLS W/SCREW HOLES, 60MM, W/P2 COATING

Model Number	430-98-060
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - due to patient presented with a dislocated acetabular cup prothesis a few weeks post-op of primary hip replacement.The surgeon took the patient back to revise the cup.
Additional Manufacturer Narrative
Corrected data: see d.8., e.1., e.2.& e.3.Manufacturer narrative: the reason for this revision surgery was reported as dislocation.The previous surgery and the surgery detailed in this event occurred 21 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 devices were disposed of at the 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 was an ncmr #46552 associated with the main part #430-98-060 fmp hemispherical shells w/screw holes, 60mm, w/p2 coating, which documents that out of 1 part lot, one part was rejected due to 1st op was not completed and parts were batched downstream for second operation.Later the rejected part was reworked and accepted after justification.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 dislocated acetabular 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.Due to short time between previous and revision surgery, it is possible that the event may have occurred due to lack of post-operative care, patient noncompliance with medical instructions or incorrect implant selection, patient activities or trauma.There are multiple factors that may also 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.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: FOUNDATION POROUS COATED HIP
• Common Device Name: FMP HEMISPHERICAL SHELLS W/SCREW HOLES, 60MM, W/P2 COATING
• Manufacturer (Section D): ENCORE MEDICAL L. P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 11782860
• Report Number: 1644408-2021-00387
• Device Sequence Number: 19878926
• Product Code: LPH
• UDI-Device Identifier: 00888912084079
• UDI-Public: (01)00888912084079
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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: 08/10/2026
• Device Model Number: 430-98-060
• Device Catalogue Number: 430-98-060
• Device Lot Number: 593G1201A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 06/03/2021
• 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: 010-55-030, LOT 007A1358; 010-55-030, LOT 007A1372A; 400-03-404, LOT 874B1107; 932-44-760, LOT 816N1965; 010-55-030, LOT 007A1358; 010-55-030, LOT 007A1372A; 400-03-404, LOT 874B1107; 932-44-760, LOT 816N1965
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR