MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK ATTUNE KNEE PATELLA

Catalog Number UNK ATTUNE KNEE PATELLA

Device Problems Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Pain (1994); No Code Available (3191)

Event Date 09/14/2018

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

Clinical adverse event received for infected left total knee arthroplasty.

Manufacturer Narrative

Product complaint # (b)(4).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.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

Manufacturer Narrative

Product complaint (b)(4).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.  h10 additional narrative: corrected: h6 (no code available (3191) is used to capture the device revision or replacement).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The previous reported device code product quality issue is being corrected to more appropriate code which is no code available (3191) to capture customer feedback: dissatisfaction.

• Brand Name: UNK ATTUNE KNEE PATELLA
• Type of Device: UNK ATTUNE KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9450206
• MDR Text Key: 170253415
• Report Number: 1818910-2019-122217
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• 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: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK ATTUNE KNEE PATELLA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUN REV OFFST STM ADPTR 4MM; ATTUNE CRS FEMORAL LT SZ 7 CEM; ATTUNE CRS RP INSRT SZ 7 6MM; ATTUNE DIST FEM AUG SZ 7 4MM; ATTUNE DIST FEM AUG SZ 7 4MM; ATTUNE POS FEM AUG SZ 7 4MM; ATTUNE POS FEM AUG SZ 7 4MM; ATUN TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM12X60MM; ATUNE PRESSFIT STR STEM16X60MM; ATUNE REV RP TIB BASE SZ 6 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 98