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

Model Number 1504-10-106

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

Patient Problem Pain (1994)

Event Date 02/05/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

The patient was revised to address medial tibial pain.No surgical delay.Doi: (b)(6) 2021, dor: (b)(6) 2021, left 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.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: no lot information available.

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

Event Description

Additional information was received stating that the number on the insert was quite worn and that is the number i interpreted it as.I cannot access the lot number on that insert as it was discarded after the case.Loosening was not a factor in this revision.Having the option marked that loosening was a factor in the surgery must have been a mistake.

• Brand Name: ATTUNE PS FEM LT SZ 6 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11365222
• MDR Text Key: 233056947
• Report Number: 1818910-2021-03620
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295041634
• UDI-Public: 10603295041634
• 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,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1504-10-106
• Device Catalogue Number: 150410106
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE PS FEM LT SZ 6 CEM; ATTUNE PS RP INSRT SZ6 6MM; ATTUNE RP TIB BASE SZ 6 CEM; ATTUNE PS FEM LT SZ 6 CEM; ATTUNE PS RP INSRT SZ6 6MM; ATTUNE RP TIB BASE SZ 6 CEM
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 106