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

Model Number	3L93713
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); Joint Laxity (4526)
Date of Event	07/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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 a revision to treat pain and instability secondary to a fractured ceramic head, a worn and chipped ceramic liner, and a stem loosened at the implant to bone interface.Head fracture revised, ceramic liner also damaged.Corail extraction device damaged upon extraction, snapped in the stem.There was a surgical delay while the surgeon located all of the pieces of the femoral head.No additional information was provided.Doi: unknown; dor: (b)(6) 2021; affected side: right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available evidence was reviewed.Based on the photo evidence provided, complaint cannot be confirmed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may 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.A manufacturing records evaluation (mre) was not performed.

• Brand Name: CORAIL2 LAT COXA VARA 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: 12432095
• Report Number: 1818910-2021-19351
• Device Sequence Number: 16971236
• Product Code: LZO
• UDI-Device Identifier: 10603295168904
• UDI-Public: 10603295168904
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K190344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/28/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3L93713
• Device Catalogue Number: 3L93713
• Device Lot Number: 5223431
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 10/07/2021; 11/01/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 10/07/2021; 11/02/2021
• 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: CORAIL2 LAT COXA VARA SIZE 13.; DELTA CER HEAD 12/14 28MM +1.5.; DELTA CER INSERT 28ID X 52OD.; PINNACLE SECTOR II CUP 52MM.; SLAP HAMMER M6/M10 ADAPTATOR.; CORAIL2 LAT COXA VARA SIZE 13; DELTA CER HEAD 12/14 28MM +1.5; DELTA CER INSERT 28ID X 52OD; PINNACLE SECTOR II CUP 52MM; SLAP HAMMER M6/M10 ADAPTATOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR