MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL AMT NECK SEG 125D STD; HIP INSTRUMENTS : FEMORAL TRIALS

Model Number	L94003
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Corail 125 short neck standard neck trial ring is loose.
Additional Manufacturer Narrative
Product complaint # (b)(4).All medical device reports associated with the same/similar device(s) and functional : loose were reviewed.It was determined functional : loose has not caused or contributed to any deaths or serious injuries within the time period of jan 1, 2018 ¿ july 12 2022.In total, there have been zero serious injuries and zero deaths reports related to visual : functional : loose in the last 4.5 years.Based on the data, the likelihood of a death or serious injury occurring as a result of the failure is remote; therefore, functional : loose associated with same/similar device(s) of this report will no longer be reported as a medical device report (mdr) unless the event results in a reportable event per 21 cfr 803.50.Correction, this event is considered not reportable after data review.(b)(4).

• Brand Name: CORAIL AMT NECK SEG 125D STD
• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14931350
• Report Number: 1818910-2022-12381
• Device Sequence Number: 11234474
• Product Code: LXH
• UDI-Device Identifier: 10603295325147
• UDI-Public: 10603295325147
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2022

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: L94003
• Device Catalogue Number: L94003
• 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: 06/21/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown