MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 CORAIL2 NON COL HO SIZE 10; HIP FEMORAL STEM

Catalog Number L20310

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Pain (1994); Tissue Damage (2104); Inadequate Osseointegration (2646); Test Result (2695); Not Applicable (3189)

Event Date 05/29/2018

Event Type  Injury  

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

Der states that the patient complained of hip pain.After doing necessary x-rays it appeared the femoral stem had shown signs of loosening.It was noted that the loosening of the stem component occurred at the bone to implant interface.It appeared to be grossly undersized as well.Because this patient had a asr cup surgeon had her metal ion levels tested and they came back high.Plan was to remove all parts and do a full revision.During the revision the stem was loose and was pulled out by hand without effort.Cup was well fixed but a small amount of metallosis was present.Cup was removed and a competitor cup was inserted to accommodate a tripolar head.Surgeon thought this was the best choice for stability.A new corail revision stem was implanted with a depuy 28 biolox ts head into a competitor tripolar head.After it was reduced it appeared to be stable through a range of motion.  doi: (b)(6) 2010; dor: (b)(6) 2018; right hip.

Manufacturer Narrative

Pc-(b)(4).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.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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 10
• 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; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7619012
• MDR Text Key: 111764308
• Report Number: 1818910-2018-62639
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295258018
• UDI-Public: 10603295258018
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: L20310
• Device Lot Number: 2755402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2018
• Date Device Manufactured: 02/11/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 97