MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 13; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number	3L92513
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Limb Fracture (4518); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Initial reporter is patient with occupation of former attorney.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Patient received primary hip-tep right side with mom on (b)(6) 2007.He is reporting pain and increased cocr-levels.Revision of acetabular components on (b)(6) 2021.Patient presented to the attending physician on (b)(6) 2020, for unspecified symptoms, for which ct scan and x-rays "showed extensive osteolysis, most likely in line with abrasion due to the metal/metal tribological pairing in the area of the trochanter region".Subsequently, the (unspecified) symptoms intensified.Additional x-rays showed that the osteolysis had broken through the trochanter region and that a minor plate had fractured off, although the trochanter region remained intact.No labs were provided that addressed metal ion levels.A right total hip revision took place on (b)(6) 2021, to address "pronounced metallosis (systemic and localized) with osteolysis in the lateral greater trochanter region on the right with metal on metal implant failure (implantation 2007)".The metal liner was reportedly "immovably corroded" to the degree that the cup and liner (with hole eliminator) had to be explanted as a whole construct.Cup, hole eliminator, metal liner, and femoral head were all revised to competitor products.The femoral stem was retained.Cultures provided no evidence of infection.No other information was provided with respect to the revision surgery.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The device manufacturing records have been reviewed.No related deviations or anomalies identified.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : the device manufacturing records have been reviewed.No related deviations or anomalies identified.Manufacture date: october 10, 2006.Device history review : the device manufacturing records have been reviewed.No related deviations or anomalies identified.Manufacture date: october 10, 2006.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: update 28-jun-2021: the investigation was re-opened up receipt of additional information.No device associated with this report was received for examination.This device was manufactured on 10-oct-2006.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot: the device manufacturing records have been reviewed.No related deviations or anomalies identified.Manufacture date: october 10, 2006.Device history review :the device manufacturing records have been reviewed.No related deviations or anomalies identified.Manufacture date: october 10, 2006.

• Brand Name: CORAIL2 STD SIZE 13
• Common Device Name: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 11566056
• Report Number: 1818910-2021-06035
• Device Sequence Number: 14191743
• Product Code: LZO
• UDI-Device Identifier: 10603295168799
• UDI-Public: 10603295168799
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2021

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 Model Number: 3L92513
• Device Catalogue Number: 3L92513
• Device Lot Number: 2240778
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 04/15/2021; 06/30/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 04/15/2021; 07/02/2021
• 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: APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +1.5; PINNACLE 100 ACET CUP 56MM; PINNACLE MTL INS NEUT36IDX56OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR