MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 5 12MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-50-512

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 10/16/2020

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 to treat joint instability secondary to insert spin out and dislocation.Extracted the attune femur, attune rp tray, and attune rp 12mm insert.Medialized dome patella was in great shape, that was not explanted.The surgeon went to a more constraint system, attune crs implants.Implanted a sz 6 crs femur, rev fixed bearing tray with offset pressfit stem and an 18mm crs fixed bearing insert.Doi: (b)(6) 2020, dor: (b)(6) 2020 (insert revised , previously reported), dor: (b)(6) 2020, 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 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 RP INSRT SZ 5 12MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10752775
• MDR Text Key: 213633679
• Report Number: 1818910-2020-23508
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295052470
• UDI-Public: 10603295052470
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1516-50-512
• Device Catalogue Number: 151650512
• Device Lot Number: 8640886
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 12/04/2020
• Supplement Dates FDA Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE PS FEM LT SZ 5 CEM; ATTUNE PS RP INSRT SZ 5 12MM; ATTUNE RP TIB BASE SZ 4 CEM; GHV SMARTSET; MEDIALIZED DOME PATELLA; ATTUNE PS FEM LT SZ 5 CEM; ATTUNE PS RP INSRT SZ 5 12MM; ATTUNE RP TIB BASE SZ 4 CEM; GHV SMARTSET; MEDIALIZED DOME PATELLA
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 122