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
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Code Available (3191)
Date of Event	01/24/2020
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 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.
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 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
• Common Device Name: EARLY INTERVENTION : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10251983
• Report Number: 1818910-2020-15411
• Device Sequence Number: 19005128
• Product Code: HRY
• UDI-Device Identifier: 10603295002741
• UDI-Public: 10603295002741
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K070267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2020

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: 1024-54-108
• Device Catalogue Number: 102454108
• Device Lot Number: J07Z32
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 07/12/2020; 08/17/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 07/16/2020; 08/17/2020
• 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: SIGMA HP UNI INS SZ1 8MM RM/LL; UNKNOWN KNEE TIBIAL TRAY; SIGMA HP UNI INS SZ1 8MM RM/LL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 8 YR
• Patient Weight: 76