MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 KAR HA FEMORAL STEM 12MM; HIP FEMORAL STEM/SLEEVE

Catalog Number L92522

Device Problems Corroded (1131); Degraded (1153); Metal Shedding Debris (1804); Osseointegration Problem (3003); Appropriate Term/Code Not Available (3191)

Patient Problems Irritation (1941); Pain (1994); Loss of Range of Motion (2032); Inadequate Osseointegration (2646)

Event Date 08/29/2016

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

On (b)(6) 2017: legal medical records received.Pfs alleges pain, lack of mobility and leg discrepancy that resulted to rotoscoliosis, and lower back pain.After review of the medical records for mdr reportability, it was stated that the patient was revised to address trunnionosis with metal debris.Patient was noted to have significantly elevate metal ions.Revision note stated that there was a significant scarring between iliotibial band and vastus lateralis, fluid from the hip, chronic granulomatous tissue noticed in the pericapsular tissue.It was also stated that there was a metal wear and damage to the superior half of the femoral taper consistent with galvanic and crevice corrosion and damage to the taper on the femoral head.Clinic notes indicate some edema around the left hip.There are no lab values provided for the reported elevated metal ions.This complaint was updated on: jul 10, 2017.

Manufacturer Narrative

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.

Manufacturer Narrative

(b)(4).

Event Description

Ppf alleges metallosis and loosening of stem.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.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.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: KAR HA FEMORAL STEM 12MM
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 6739586
• MDR Text Key: 80875871
• Report Number: 1818910-2017-21675
• 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: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2016
• Device Catalogue Number: L92522
• Device Lot Number: 5045121
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 54