MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT SZ10 135 LOW COL; CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM

Catalog Number	L971310
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
The primary surgery was performed on (b)(6) 2018 via tha.Two weeks after the primary surgery, the surgeon recognized that the stem was rotated in the medullary cavity, so that the it was dislocated.It was reported that the revision surgery was performed on (b)(6) 2018.The surgeon commented that the size of the stem which initially implanted might have been under sized.
Additional Manufacturer Narrative
(b)(4).Investigation summary no products were returned.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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 AMT SZ10 135 LOW 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: 7734584
• Report Number: 1818910-2018-65469
• Device Sequence Number: 10963918
• Product Code: JDG
• UDI-Device Identifier: 10603295455448
• UDI-Public: 10603295455448
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2018

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: L971310
• Device Lot Number: 8599862
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 08/24/2018
• 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
• Patient Age: 89 YR
• Patient Weight: 46