MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT SZ16 135 HIGH COL; CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM

Model Number	L971116
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/08/2021
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
Revision of primary corail with competitor acetubular cup (also revised) reason for revision femoral stem neck fracture.Initially done in 2018, revised today by surgeon.Fatigue failure propagating from the superior neck.Clean fracture line superiorly without abrasion of the fracture face.Plastic deformity inferiority with evidence of strain beyond yield but only inferiority.No identifiable surface defect as a stress focus superiorly.No evidence of neck impingement on either the neck or acetabular components.No corrosion otherwise, the fracture started proximal to the threaded hole and i didn't inspect the taper.
Event or Problem Description
Affected side: left side.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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 : product code l971116, work order (b)(4) was manufactured on 15 sep 2015.(b)(4) parts were manufactured per specification and all raw materials met specification.Scrap: there was no scrap associated with this lot.Reprocessing: there was no material reprocessing reports (mrr) associated with this lot.Non-conformance: 1 non-conformance associated with this lot.Nr-0084452 relates to ctq 8 inspection activity on the cmms at machining and linish/polish process steps.It is determined that there is no correlation between this non-conformance and the failure mode of the complaint.

• Brand Name: CORAIL AMT SZ16 135 HIGH COL
• Common Device Name: CORAIL LINE EXTENSION IMPLANTS : 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: 12264588
• Report Number: 1818910-2021-16784
• Device Sequence Number: 5128094
• Product Code: LZO
• UDI-Device Identifier: 10603295455356
• UDI-Public: 10603295455356
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K190344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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
• Report Date (Section B): 07/09/2021

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: L971116
• Device Catalogue Number: L971116
• Device Lot Number: 8159622
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 09/09/2021
• 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: COMPETITOR; CORAIL AMT SZ16 135 HIGH COL; DELTA CER HEAD 12/14 28MM +8.5; COMPETITOR; CORAIL AMT SZ16 135 HIGH COL; DELTA CER HEAD 12/14 28MM +8.5
• Outcome Attributed to Adverse Event: Required Intervention