MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV LPS INSRT XSM 14MM; KNEE TIBIAL INSERT

Model Number	1517-60-214
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	04/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgeon made rep aware that a patient with a lps-attune rev construct in dislocated the poly insert and would need to come in for revision surgery to exchange the poly insert for a thicker one.The insert was a attune revision-lps 14mm x-small insert.Surgeon stated that the patient had a dislocated patella, which resulted in a lack of anterior stability of the knee, which resulted in the femur translating anteriorly and dislocating the poly insert.At the time of surgery, when the knee was opened up, the surgeon found that the poly insert had dissociated from the metal core that is part of the insert.This means that the metal core was still attached to the femoral component via the hinge pin; however, the rest of the poly insert was not attached to any other part of the construct.Doi: (b)(6) 2021.Dor: (b)(6) 2022.Unknown side.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was received for examination.Based on the provided photographic evidence it can be confirmed that poly insert and metal core were disassociated.Both components can be observed separated.However, the visual examination of the part denoted that device was reassembled post operatively and it was not possible to disengage them.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 REV LPS INSRT XSM 14MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14315930
• Report Number: 1818910-2022-08359
• Device Sequence Number: 5223988
• Product Code: JWH
• UDI-Device Identifier: 10603295490975
• UDI-Public: 10603295490975
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 05/06/2022

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: 1517-60-214
• Device Catalogue Number: 151760214
• Device Lot Number: SI499332 (FRONT), ST177313 (BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 05/13/2022; 06/09/2022; 07/11/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 05/20/2022; 06/13/2022; 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 REV LPS INSRT XSM 14MM; UNKNOWN KNEE FEMORAL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female