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

Model Number	1516-50-512
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10752775
• Report Number: 1818910-2020-23508
• Device Sequence Number: 19662570
• Product Code: NJL
• UDI-Device Identifier: 10603295052470
• UDI-Public: 10603295052470
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 1516-50-512
• Device Catalogue Number: 151650512
• Device Lot Number: 8640886
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Weight: 122