MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA TC3 FEM RT SZ3; SIGMA REVISION IMPLANT : KNEE FEMORAL

Model Number	96-0088
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loss of Osseointegration (2408); Illegible Information (4050)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); 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
The patient was revised to address pain and loosening of the femoral component at the bone to implant interface.No surgical delay.Doi: unknown; dor: (b)(6) 2020; right knee.
Event or Problem Description
Additional information received indicated that the entire construct was loose.
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.Corrected: h6 (clinical code) retracting the reported code for inadequate osteointegration (2646).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history review : product/lot information is not available.

• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10782397
• Report Number: 1818910-2020-23885
• Device Sequence Number: 14180344
• Product Code: JWH
• UDI-Device Identifier: 10603295232551
• UDI-Public: 10603295232551
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/19/2020

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: 96-0088
• Device Catalogue Number: 960088
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 12/08/2020; 12/09/2020; 12/15/2020; 12/16/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 12/08/2020; 12/09/2020; 12/16/2020; 12/17/2020
• 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: TC3 FEMORAL SLEEVE; TC3 FLUTED STEM; TC3 RP INSERT; UNKNOWN KNEE FEMORAL; UNKNOWN KNEE FEMORAL SLEEVE; UNKNOWN KNEE FEMORAL STEM; UNKNOWN KNEE TIBIAL INSERT; UNKNOWN KNEE FEMORAL; UNKNOWN KNEE FEMORAL SLEEVE; UNKNOWN KNEE FEMORAL STEM; UNKNOWN KNEE TIBIAL INSERT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 154