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

Model Number 96-0088

Device Problems Loss of or Failure to Bond (1068); Loss of Osseointegration (2408); Illegible Information (4050)

Patient Problems Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 10/19/2020

Event Type  Injury  

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 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 Description

Additional information received indicated that the entire construct was loose.

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).

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.

• Type of Device: SIGMA REVISION IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10782397
• MDR Text Key: 214522078
• Report Number: 1818910-2020-23885
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295232551
• UDI-Public: 10603295232551
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 96-0088
• Device Catalogue Number: 960088
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 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
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 154