MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Syncope (1610); Fatigue (1849); Foreign Body Reaction (1868); Nausea (1970); Pain (1994); Weakness (2145); Discomfort (2330); Depression (2361); Test Result (2695); No Code Available (3191)

Event Date 05/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Asr claim letter and medical records received.Claim letter alleges pain, dizziness, nausea, weakness, fainting, fatigue, discomfort, depression, post-traumatic stress disorder, prostatic adenocarcinoma these signs and symptoms and diagnosis were due to metal poisoning, heavy metals cobalt and chromium in the body.Lab reports above 7 ppb.Claimant is seeking for damages.After review of medical records the patient was revised due to mechanical complication of internal joint prosthesis resulting to metallosis, elevated metal ions, vertigo and limping.Doi: (b)(6) 2008.Dor: (b)(6) 2017; left hip.

Manufacturer Narrative

H10 additional narrative: product complaint #
=
> pc-(b)(4).Investigation summary
=
> no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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: UNKNOWN HIP FEMORAL STEM
• Type of Device: 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: 9943353
• MDR Text Key: 187512965
• Report Number: 1818910-2020-10552
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR