MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 6 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-30-610
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	10/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).(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
Revision of primary attune knee cr rp components, with primary cause being bearing spin out.Primary operation was on (b)(6) 2020.Put in a 6n left cr femur, size 5 rp base plate, size 6, 7mm cr rp insert and 32 anatomic patella.Patient presented on (b)(6) 2020 with bearing spinout, and had a bearing exchange to 10mm insert.It was found here that pcl had been ruptured post the index procedure.Patient was put into a rom brace, but despite that suffered another spin out within 2 weeks.So today they were revised with removal of all components, and replaced with sz 4 attune revision rp tibia with 37 sleeve and 60mm stem, size 6 revision femur with posterior augments and 110 stem, and a 6, 16mm revision insert.In balancing the knee it was apparent that the patient's flexion gap was significantly looser than extension, so the surgeon sacrificed some joint line in order to balance extension to flexion.The lcl required some repair, and the surgeon wonders whether this is one potential cause of such significant instability.Doi: (b)(6) 2020 dor: (b)(6) 2020 (insert exchange) dor: (b)(6) 2020 (total revision) left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot: a worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.

• Brand Name: ATTUNE CR RP INSRT SZ 6 10MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10719450
• Report Number: 1818910-2020-23093
• Device Sequence Number: 1139776
• Product Code: NJL
• UDI-Device Identifier: 10603295047902
• UDI-Public: 10603295047902
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2020

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: 1516-30-610
• Device Catalogue Number: 151630610
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 12/10/2020
• 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: 32 ANATOMIC PATELLA; ATTUNE CR FEM LT SZ 6 NAR CEM; ATTUNE CR RP INSRT SZ 6 10MM; ATTUNE RP TIB BASE SZ 5 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR