MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL REVISION STEM STD 18; HIP FEMORAL STEM/SLEEVE

Catalog Number	L98018
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/23/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Patient initiated complaint form received.It was reported by the patient that he had blood test ran and he does in fact have allergies to certain metals.He is suffering chronic pain, and is concerned that he may be allergic to the metals which make up his hip implant.
Additional Manufacturer Narrative
Update 10-20-2017: medical records have been reviewed.Primary procedure notes (b)(6) 2013 indicate the patient please disregard this medwatch as it was reported in error.No revision, no serious injury at this time.Please note, this adverse event is about the current pain and possible allergic reaction to metals the patient is experiencing.There has not been an additional revision after (b)(6) 2014.If an additional revision occurs this decision will be re-addressed.
Additional Manufacturer Narrative
This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.  product complaint # = > pc-(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CORAIL REVISION STEM STD 18
• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 6855152
• Report Number: 1818910-2017-24435
• Device Sequence Number: 636513
• Product Code: LWJ
• UDI-Device Identifier: 10603295262367
• UDI-Public: 10603295262367
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K093736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: L98018
• Device Lot Number: 7894030
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2017
• Supplement Date Received by Manufacturer: 10/20/2017; 05/09/2018
• Initial Report FDA Received Date: 09/11/2017
• Supplement Report FDA Received Date: 11/13/2017; 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention