MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 6 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-206

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Fall (1848); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/21/2021

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

Patient was revised due fall and possible medial femur injury leading to loosening of femoral component at cement to implant interface and loosening of the tibial component at cement to bone interface.Depuy cement was used.Doi: (b)(6) 2019 dor: (b)(6) 2021 right knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE PS FEM RT SZ 6 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11791070
• MDR Text Key: 249515300
• Report Number: 1818910-2021-09770
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295041771
• UDI-Public: 10603295041771
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1504-10-206
• Device Catalogue Number: 150410206
• Device Lot Number: 8952407
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 7 CEM; ATTUNE PS FB INSRT SZ 6 5MM; ATTUNE PS FEM RT SZ 6 CEM; UNK CEMENT SMARTSET; ATTUNE FB TIB BASE SZ 7 CEM; ATTUNE PS FB INSRT SZ 6 5MM; ATTUNE PS FEM RT SZ 6 CEM; UNK CEMENT SMARTSET
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 83