MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 3 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-30-307
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	01/15/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Patient dislocated due to gross instability.Revised femur.
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.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: dhr review: product code 151630307 work order (b)(4) was manufactured on 27-sep-2017.14 parts were manufactured per specification and all raw materials met specification.There were three scrap parts associated with lot (b)(4).The three parts were scrapped off at the machining step in the process.The three parts were scrapped out for the reason code a640: swarf on fixture.All part at the machining step in the process are 100 percent inspected on a cmm.The cmm reports were reviewed as parts of this dhr review.All scrap parts were removed from lot (b)(4) as per scp-csop0619 scrap procedure, therefore there is no correlation with the complaint failure mode.One ncs (non-conformances) found associated with (b)(4).Nr-0102929 was opened in relation to surface roughness in the patella relief out of specification.Nr-0102929 was escalated to pia.During further investigation under product issue assessment (pia) 1236841 the product issue does not alter the benefit-risk profile of this product.As there is no increased risk to patient safety.Based on the above there is no correlation between nr-0102929 and the complaint failure mode of patient dislocated due to gross instability.

• Brand Name: ATTUNE CR RP INSRT SZ 3 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11243979
• Report Number: 1818910-2021-01989
• Device Sequence Number: 3571282
• Product Code: NJL
• UDI-Device Identifier: 10603295047520
• UDI-Public: 10603295047520
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2021
• 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): 01/15/2021

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: 1516-30-307
• Device Catalogue Number: 151630307
• Device Lot Number: 8627492
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 03/15/2021
• 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 CR FEM LT SZ 3 CEM; ATTUNE CR RP INSRT SZ 3 7MM; ATTUNE CR FEM LT SZ 3 CEM; ATTUNE CR RP INSRT SZ 3 7MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR