MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 7 14MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-40-714
Medical Device Problem Codes	Use of Device Problem (1670); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Joint Dislocation (2374); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/26/2021
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
A patient was admitted for surgery to repair a dislocated attune knee.It was not disclosed how long this patient had gone since primary knee surgery.Intra-operatively, the joint capsule was grossly swollen and expelled copious amounts of fluid during incision into the joint capsule.It is unclear what initiated the fluid buildup in the joint.Upon reaching the joint-space, it was observed that a attune sz 7 ps fb poly insert had become inverted following its dislocation from the fb tibial tray in the joint-space.The poly insert was severely deformed.The surgeons looked for possible fragments but none were found within the joint-space to remove.Cultures were taken for possible infection.The knee was washed thoroughly with saline and antiseptic solution.Another size 7 ps fb poly was inserted in its place.The surgeon commented that this was the first attune ps fb insert that had dissociated from the fb tibial tray.Doi: unknown, dor: (b)(6) 2021, unknown side.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.All available photographs were reviewed, and evidence of abnormal wear and disassociation was found.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: there's no lot number provided, therefore a worldwide complaint database search couldn't been performed to determine if a lot related issue was possible.A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE PS FB INSRT SZ 7 14MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12482019
• Report Number: 1818910-2021-20286
• Device Sequence Number: 3821320
• Product Code: JWH
• UDI-Device Identifier: 10603295050261
• UDI-Public: 10603295050261
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2021

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: 1516-40-714
• Device Catalogue Number: 151640714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 10/18/2021; 11/19/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 10/25/2021; 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE PS FB INSRT SZ 7 14MM.; UNK ATTUNE KNEE TIBIAL TRAY.; ATTUNE PS FB INSRT SZ 7 14MM; UNK ATTUNE KNEE TIBIAL TRAY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 130 KG