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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Adhesion(s) (1695); Fall (1848); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 05/06/2015

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Complaint description: patient has experienced a possible allergic reaction, pain and stem and cup loosening.Revision implant date (b)(6) 2014.Update rec'd 14 may, 2015 - the patient's medical records were received.Medical records were reviewed for mdr reportability.There is no new information that would change the existing mdr decision.The complaint was updated on: 10 june, 2015.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.No code available (3191) is used to capture device revision or replacement.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

After review of medical result mri reported metallosis from trunnion, fluid collection around the hip have increase and significant joint effusion.Patient letter allege walking difficulty, scars and suggest fluid around hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary - no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• 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: 10246282
• MDR Text Key: 198020182
• Report Number: 1818910-2020-15277
• Device Sequence Number: 1
• Product Code: KWY
• 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,Followup
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN HIP ACETABULAR CUP.; UNKNOWN HIP ACETABULAR LINERS.; UNKNOWN HIP FEMORAL HEAD.; UNKNOWN HIP FEMORAL STEM; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR