MAUDE Adverse Event Report: DEPUY FRANCE SAS-3003895575 CORAIL2 STD SIZE 8; HIP FEMORAL STEM/SLEEVE

Catalog Number 3L92507

Device Problems Loss of or Failure to Bond (1068); Metal Shedding Debris (1804)

Patient Problems Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)

Event Date 02/18/2014

Event Type  Injury  

Event Description

Asr revision, asr xl- right, reason(s) for revision: unknown.Surgeon confirmation form received (b)(6) 2014.Revision reasons added.Reason(s) for revision: component loosening (stem), pain.

Manufacturer Narrative

No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Asr revision; asr xl- right; reason(s) for revision: unknown.Surgeon confirmation form received (b)(4) 2014.Revision reasons added.Reason(s) for revision: component loosening (stem), pain.Update received: (b)(4) 2014 - added (b)(4) reference number, marked as legal, added hospital: (b)(6) and added surgeon: dr (b)(6).

Manufacturer Narrative

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

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Depuy still considers this case closed to capa.

Event Description

Asr revision.Asr xl- right.Reason(s) for revision: unknown.Surgeon confirmation form received 9th april 2014.Revision reasons added.Reason(s) for revision: component loosening (stem), pain.Update received: 25th april 2014 - added (b)(6) reference number, marked as legal, added hospital: clinique (b)(6) and added surgeon: dr (b)(6).Partial patient demographics received 16th july 2014.Queried three times but remaining patient demographics have not been received.X-rays, blood test results and operative notes added.Patient sex, dob, occupation ((b)(6)) added.Additional reasons for revision added: reason(s) for revision: component loosening (stem), pain, elevated cobalt and chromium.Metallosis additional information received 29th july 2014.X-ray, patient height and weight added.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Depuy still considers this case closed to capa.

Event Description

Asr revision, asr xl- right, reason(s) for revision: unknown.Surgeon confirmation form received 9th april 2014.Revision reasons added.Reason(s) for revision: component loosening (stem), pain update received: 25th april 2014 - added (b)(6) reference number, marked as legal, added hospital: (b)(6) and added surgeon: (b)(6).Partial patient demographics received 16th july 2014.Queried three times but remaining patient demographics have not been received.X-rays, blood test results and operative notes added.Patient sex, dob, occupation (self employed - cleaning company) added.Additional reasons for revision added: reason(s) for revision: component loosening (stem), pain, elevated cobalt and chromium.Metallosis.

• Brand Name: CORAIL2 STD SIZE 8
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY FRANCE SAS-3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex 6980 1; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS-3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex 6980 1; FR 69801
• Manufacturer Contact: stacey trick ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714554
• MDR Report Key: 3749868
• MDR Text Key: 4480041
• Report Number: 1818910-2014-16786
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/05/2014

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
• Device Operator: Physician
• Device Catalogue Number: 3L92507
• Device Lot Number: 2129135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/05/2014
• Initial Date FDA Received: 04/15/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/15/2014; 07/28/2014; 08/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2006
• 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: 55 YR
• Patient Weight: 89