MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 CORAIL2 LAT COXA VARA SIZE 13; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number	3L93713
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Cyst(s) (1800); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994)
Date of Event	06/10/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.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
Asr claim and medical records received.After review of medical records patient was revised to addressed painful left hip with metal on metal bearing with trunnion metallosis that most likely cause of the irritation.Mri showed a large cyst like lesions compatible with the metal on metal bearing.There was not an abnormal amount of wear, although there were some small burnished marks on the femoral head.The trunnion was quite coated with a thick black residue.Acetabular cup was solidly fixed, lightly burnished but not scratched.Doi: (b)(6) 2006.Dor: (b)(6) 2014, left hip.
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 material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).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 ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 12547126
• Report Number: 1818910-2021-21397
• Device Sequence Number: 11759714
• Product Code: LZO
• UDI-Device Identifier: 10603295168904
• UDI-Public: 10603295168904
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K190344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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: 2064735
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 10/27/2021
• 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: ADAPTER SLEEVES 12/14 +2.; ASR ACETABULAR CUPS 60.; ASR UNI FEMORAL IMPL SIZE 53.; CORAIL2 LAT COXA VARA SIZE 13.; ADAPTER SLEEVES 12/14 +2; ASR ACETABULAR CUPS 60; ASR UNI FEMORAL IMPL SIZE 53; CORAIL2 LAT COXA VARA SIZE 13
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR