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

Model Number	L98011
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
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
The surgeon sent me the x-rays of a hip replacement that he needs to review because the patient is in great pain.Then he called me to fix the date of the revision and then he asked me if i noticed that the stem was fractured in 2 places.There has been no surgical intervention and/or invasive treatment performed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned femoral stem confirms the reported material fracture.The stem was evaluated by a depuy material scientist.The root cause was attributed to fatigue.No material or manufacturing defects were observed in the titanium femoral stem that could have contributed to fracture 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  h6 patient code: no code available (3191) used to capture device revision ore replacement patient code.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = examination of the returned femoral stem confirms the reported material fracture.The stem was evaluated by a depuy material scientist.The root cause was attributed to fatigue.No material or manufacturing defects were observed in the titanium femoral stem that could have contributed to fracture 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.Device history lot = lot 5018624.A device manufacturing (dhr) and material certification records review was requested.The dhr and material certification analysis showed an initial conformance of this product / lot with regards to its specification.There was no deviation or non-conformance.

• Brand Name: KAR HA FEMORAL STEM 14MM
• Common Device Name: CORAIL KAR REVISION IMPLANT : 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: 9872450
• Report Number: 1818910-2020-09060
• Device Sequence Number: 19668705
• Product Code: LZO
• UDI-Device Identifier: 10603295262305
• UDI-Public: 10603295262305
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K961732
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: L98011
• Device Catalogue Number: L92524
• Device Lot Number: 5018624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 05/14/2020; 06/22/2020; 06/29/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 05/27/2020; 06/23/2020; 07/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORAIL REVISION STEM STD 11; CORAIL REVISION STEM STD 11