MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ1 8MM RM/LL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Model Number 1024-54-108

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); No Code Available (3191)

Event Date 01/24/2020

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 a dislodged tibial insert.A new tibial insert was implanted.No additional information is available.Doi: (b)(6) 2020, dor: (b)(6) 2020, left knee.

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.

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.H10 additional narrative: corrected: d11, h6 (patient) removed code for joint dislocation and replaced with no code available (3191) for insufficient information.

• Brand Name: SIGMA HP UNI INS SZ1 8MM RM/LL
• Type of Device: EARLY INTERVENTION : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10251983
• MDR Text Key: 198151202
• Report Number: 1818910-2020-15411
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295002741
• UDI-Public: 10603295002741
• Combination Product (y/n): N
• PMA/PMN Number: K070267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1024-54-108
• Device Catalogue Number: 102454108
• Device Lot Number: J07Z32
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SIGMA HP UNI INS SZ1 8MM RM/LL; UNKNOWN KNEE TIBIAL TRAY; SIGMA HP UNI INS SZ1 8MM RM/LL
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR
• Patient Weight: 76