MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 CORAIL REVISION STEM STD 14; CORAIL KAR REVISION IMPLANT : HIP FEMORAL STEM

Catalog Number	L98014
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	12/08/2017
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
Patient was revised to address pathological femur fracture and loosening of the stem at the bone to implant interface.Femoral component of total hip subsided significantly.Surgeon believed this was a result of the comprise of the bone from cancer and the radiation and chemotherapy to treat it.Doi: (b)(6) 2017; dor: (b)(6) 2017; left hip.
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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 14
• Common Device Name: CORAIL KAR REVISION IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; st priest cedex, rhone-alpes 69801 ; FR 69801
• MDR Report Key: 7167592
• Report Number: 1818910-2018-50337
• Device Sequence Number: 19331373
• Product Code: LWJ
• UDI-Device Identifier: 10603295262336
• UDI-Public: 10603295262336
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K093736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2017

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: L98014
• Device Lot Number: 7786009
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/08/2017
• Supplement Date Received by Manufacturer: 02/02/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 02/05/2018
• 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