MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 CORAIL2 NON COL HO SIZE 12; HIP FEMORAL STEM

Catalog Number L20312

Device Problems Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Bone Fracture(s) (1870); Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646)

Event Date 01/13/2017

Event Type  Injury  

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 Description

Update ad 26 jan 2018: pinnacle litigation record received.Litigation alleges pain, discomfort, and abnormally high levels of cobalt and chromium.Litigation stated that there is a right hip revision on (b)(6) 2017 , however it did not mention that the patient is bilateral.Shall there be new information received, this complaint will be updated and another complaint will be created as necessary.Doi: (b)(6) 2009 -dor: not reported (left hip).

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pinnacle ppf and implant sticker received.Ppf alleges bone fracture, loosening of stem, metal wear and metallosis confirmed in medical records.Ppf stated that the liner , head and stem was the only revised products.Doi: (b)(6) 2009; dor: (b)(6) 2017; left hip.

Manufacturer Narrative

Product complaint #: (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: CORAIL2 NON COL HO SIZE 12
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; b.p. 256; leeds 69801 ; UK 69801
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7279776
• MDR Text Key: 100399128
• Report Number: 1818910-2018-53585
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 10603295258032
• UDI-Public: 10603295258032
• Combination Product (y/n): N
• PMA/PMN Number: K123991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2014
• Device Catalogue Number: L20312
• Device Lot Number: 5000736
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2018
• Date Device Manufactured: 03/19/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR