MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA STAB GVF INS 3 15MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-23-015
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/19/2020
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
Initial surgery was (b)(6) 2015 and inserted 158123015 sigma stab gvf size 3 15mm.Taken back for surgery today due to instability and replaced insert and did the patella.On investigation the spine broke off poly insert.If other, describe --> total knee replacement., patient status/ outcome / consequences --> no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> yes, if yes, describe --> poly exchange 5 years post surgery.158123115., is the patient part of a clinical study --> no, (b)(4).Device property of -->none, device in possession of -->none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.--> true.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not 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: a manufacturing record evaluation were performed for the finished device dhr 158123015 / d11050899, it was manufactured on 16-may-2011.(b)(4) parts were manufactured per specification and all raw materials met specification, and no non-conformances were identified.

• Brand Name: SIGMA STAB GVF INS 3 15MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10784886
• Report Number: 1818910-2020-23894
• Device Sequence Number: 19560536
• Product Code: JWH
• UDI-Device Identifier: 10603295064275
• UDI-Public: 10603295064275
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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,Followup
• Report Date (Section B): 10/16/2020

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: 1581-23-015
• Device Catalogue Number: 158123015
• Device Lot Number: D11050899
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 01/05/2021; 01/11/2021
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 01/08/2021; 01/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR