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

Catalog Number L92524

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 06/17/2020

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

Patient presented with hip pain.X-rays showed that the stem appeared loose.The depuy stem, head and insert were removed.Surgeon noted that there was no sign of infection, however swabs were taken.A new depuy synthes marathon cup was reimplanted into the pinnacle acetabular cup.For the femoral side, the surgeon chose to implant a medacta stem and head.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : 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.Corrective action was not indicated.

• Brand Name: KAR HA FEMORAL STEM 14MM
• Type of Device: 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: 10213099
• MDR Text Key: 197023009
• Report Number: 1818910-2020-14696
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K961732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: L92524
• Device Lot Number: 2276148
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICULEZE M HEAD 36MM +1.5; PINN MAR +4 10D 36IDX60OD; UNKNOWN HIP ACETABULAR CUP; ARTICULEZE M HEAD 36MM +1.5; PINN MAR +4 10D 36IDX60OD; UNKNOWN HIP ACETABULAR CUP
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR