MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 CORAIL REVISION STEM STD 15; CORAIL KAR REVISION IMPLANT : HIP FEMORAL STEM

Model Number	L98015
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Limb Fracture (4518); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
It was reported that the stem distal slots deformed intro-op.The patient underwent the hip revision surgery with corail revision stem.With x-ray examination during the surgery, it was found that the stem distal slot was deformed.Then the surgeon removed the deformed stem timely and used another revision stem to complete the surgery.The patient was stable now.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received indicated that the examination of the provided x-ray image showed that the distal tip of the stem has perforated the patient's femoral bone.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received indicated that there was a 20 minutes surgical delay and the affected side involved in this event was the right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The photo investigation can confirm the reported allegation.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 : l98015/ 5376201 quantity manufactured: (b)(4).Date of manufacture: 04-march-2021.Any anomalies or deviations identified in dhr: none.Expire date: 31-january-2026.Ifu reference: ifu-w90914 rev.B.Device history review : l98015/ 5376201.Quantity manufactured: (b)(4) date of manufacture: 04-march-2021.Any anomalies or deviations identified in dhr: none.Expire date: 31-january-2026.Ifu reference: ifu-w90914 rev.B.

• Brand Name: CORAIL REVISION STEM STD 15
• Common Device Name: CORAIL KAR REVISION IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot curie; b.p. 256; st. priest cedex IN 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot curie; b.p. 256; st. priest cedex IN 69801 ; FR 69801
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13025081
• Report Number: 1818910-2021-28338
• Device Sequence Number: 1727119
• Product Code: LZO
• UDI-Device Identifier: 10603295262343
• UDI-Public: 10603295262343
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/17/2021

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: L98015
• Device Catalogue Number: L98015
• Device Lot Number: 5376201
• 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: 12/06/2021
• Supplement Date Received by Manufacturer: 12/06/2021; 01/03/2022; 01/05/2022; 03/01/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 12/24/2021; 01/06/2022; 01/20/2022; 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• 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: ARTICUL/EZE BALL 32 +5 BR; UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown