MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 STD SIZE 10; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number	3L92510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Discomfort (2330); Unspecified Tissue Injury (4559)
Date of Event	08/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2020, the patient underwent the total hip arthroplasty with the pinnacle procoat, the stem, the head and the altrx for the left hip joint at (b)(6) hospital in china.The surgery was completed successfully without any surgical delay.After the surgery, the patient visited (b)(6) hospital for discomfort.On (b)(6) 2022, the revision surgery was performed.The surgeon measured the cup with the ct before the surgery, and the cup was 50 degrees and had not moved that far.According to the surgeon, the sequence of the event is as follows.First, the lip of the offset liner was broken, and dislocation occurred.Next, the liner dislocated, and the ceramic head scratched and destroyed the cup.The wound was black due to metallosis.The surgeon removed the head, and the liner was taken off easily.The surgeon removed the cup with an explant tool.After removal, the surgeon inserted zb¿s dual mobility and a head.The head and the cup will be replaced with other company¿s cup.According to the surgeon, after destruction of polyethylene, the cup was broken by ceramic head.Next, dislocation occurred, and destruction of bone matrix floor was suspected.Since the primary surgery was performed in china two years ago, the details and the cause of the event are unknown.In addition, it is unknown if it is the strength of the offset liner or the polyethylene itself.The surgeon commented that the patient¿s young age and high level of activity is one of the causes.No further information is available.Doi: (b)(6) 2020.Dor: (b)(6) 2022.Unknown hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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 product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: CORAIL2 STD SIZE 10
• 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
• Manufacturer (Section G): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15282659
• Report Number: 1818910-2022-16541
• Device Sequence Number: 2392876
• Product Code: LZO
• UDI-Device Identifier: 10603295168768
• UDI-Public: 10603295168768
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2022

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: 3L92510
• Device Catalogue Number: 3L92510
• Device Lot Number: 9141889
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALTRX +4 10D 32IDX50OD; CORAIL2 STD SIZE 10; DELTA CER HEAD 12/14 32MM +1; PINNACLE 100 ACET CUP 50MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male