MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 COR VAR NECK SEGMENT COR AMT; HIP INSTRUMENTS : FEMORAL TRIALS

Model Number	L20432
Medical Device Problem Codes	Material Twisted/Bent (2981); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2021
Type of Reportable Event	Malfunction
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
It was reported that the instruments were worn ¿ all been in service circa 10 years and have worn.No impact on patient.No delay to surgery.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the instrument associated with this report was not returned.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.Material twisted/bent was updated to naturally worn.

• Brand Name: COR VAR NECK SEGMENT COR AMT
• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot curie; b.p. 256; st. priest cedex IN 9801 ; FR 9801
• MDR Report Key: 12154809
• Report Number: 1818910-2021-14999
• Device Sequence Number: 11937201
• Product Code: LXH
• UDI-Device Identifier: 10603295258223
• UDI-Public: 10603295258223
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: L20432
• Device Catalogue Number: L20432
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 07/15/2021; 09/09/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 07/19/2021; 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1