MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 2 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-202

Device Problem Migration (4003)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Deformity/ Disfigurement (2360); Not Applicable (3189)

Event Date 08/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Concomitant medical products: attune ps fb insrt sz 2 8mm, 151640208; attune fb tib base sz 2 cem, 150600002.

Event Description

The patient was revised to address loosening of the femur at bone to cement interface.Depuy cement was used.It was also reported that femoral had subsided laterally.No trauma per patient.Doi: unknown; dor: (b)(6) 2018; right knee.

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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Medical records alleges pain, femoral bone fracture and disfigurement.

Manufacturer Narrative

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.  additional narrative:   udi:(b)(4).Added: patient identifier, description of event or problem, other relevant history, device identification (expiration date), report source and evaluation codes (patient).

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: ATTUNE PS FEM RT SZ 2 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7880532
• MDR Text Key: 120393586
• Report Number: 1818910-2018-69470
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295041733
• UDI-Public: 10603295041733
• Combination Product (y/n): N
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1504-10-202
• Device Catalogue Number: 150410202
• Device Lot Number: C83747
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR