MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FEM LT SZ5; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	96-0005
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgeon is reporting a fracture of a knee-tep´s femoral condyle.Doi: unknown.Dor: (b)(6) 2022.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 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 returned to depuy synthes for evaluation.Visual examination of the device and the photo investigation confirmed the reported allegation.The device presents a fracture on the medial condyle.Additionally cement and some interdigitation on the inner concave surface of the device can be observed, suggesting some level of fixation.The broken part was returned.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: lot# 3370092 1) quantity manufactured: 10 2) date of manufacture: 10-oct-2011 3) any anomalies or deviations identified in dhr: there was no non-conformances associated with this lot 4) expiry date: october-2016 5) ifu reference: ifu: 090200252 device history batch : null device history review: lot# 3370092 1) quantity manufactured: 10 2) date of manufacture: 10-oct-2011 3) any anomalies or deviations identified in dhr: there was no non-conformances associated with this lot 4) expiry date: october-2016 5) ifu reference: ifu: 090200252.

• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15985998
• Report Number: 1818910-2022-25475
• Device Sequence Number: 5995862
• Product Code: JWH
• UDI-Device Identifier: 10603295231974
• UDI-Public: 10603295231974
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K943462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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
• Report Date (Section B): 12/15/2022

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: 96-0005
• Device Catalogue Number: 960005
• Device Lot Number: 3370092
• 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: 11/29/2022
• Supplement Date Received by Manufacturer: 01/05/2023; 02/06/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 01/09/2023; 02/06/2023
• 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: PALACOS CEMENT (UNK MANUFACTURER); PFC*SIGMA C/R NPOR FEM LT SZ5; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIG MOD TIB TRAY CEM COCR 4; SIGMA CRVD XLK INS 4 10MM; UNKNOWN KNEE FEMUR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown